mitchell cayen n early drug development strategies and routes to first in human trials



Mitchell Cayen N. Early Drug Development. Strategies and Routes to First-in-Human Trials Mitchell Cayen N. Early Drug Development. Strategies and Routes to First-in-Human Trials Новинка

Mitchell Cayen N. Early Drug Development. Strategies and Routes to First-in-Human Trials

14568.24 руб.
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Henry Riordan Critical Pathways to Success in CNS Drug Development Henry Riordan Critical Pathways to Success in CNS Drug Development Новинка

Henry Riordan Critical Pathways to Success in CNS Drug Development

14669.08 руб.
Covering the latest advances in CNS drug development, this book will guide all those involved in pre-clinical to early clinical trials. The authors describe how recent innovations can accelerate the development of novel CNS compounds, improve early detection of efficacy and toxicity signals, and increase the safety of later-stage clinical trials. The current crisis in the drug development industry is critically reviewed, as well as the steps needed to correct the problems, including new government-backed regulations and industry-based innovations designed to accelerate CNS drug development in the future. Animal-based models of major CNS disorders are described in detail, and the ability of the latest in vitro and computer-based models to simulate CNS disease states and predict drug efficacy and side-effects are examined. Particular attention is given to the growing use of biomarkers and how they can be used effectively in early human trials as signals of potential drug efficacy, as well as the increasingly important role of imaging studies to guide dose selection. Cognitive assessments that can be useful indicators of effect in patient populations are also discussed. Written by a team of clinical scientists involved in CNS drug trials for over 20 years, and based on a wealth of drug development and clinical trial experience, Critical Pathways to Success in CNS Drug Developmentis full of practical advice for successfully designing and executing CNS drug trials, avoiding potential pitfalls, and complying with government regulations
Sara A. Hurvitz Antibody-Drug Conjugates. Fundamentals, Drug Development, and Clinical Outcomes to Target Cancer Sara A. Hurvitz Antibody-Drug Conjugates. Fundamentals, Drug Development, and Clinical Outcomes to Target Cancer Новинка

Sara A. Hurvitz Antibody-Drug Conjugates. Fundamentals, Drug Development, and Clinical Outcomes to Target Cancer

11896.9 руб.
Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development
Elizabeth Kwong Oral Formulation Roadmap from Early Drug Discovery to Development Elizabeth Kwong Oral Formulation Roadmap from Early Drug Discovery to Development Новинка

Elizabeth Kwong Oral Formulation Roadmap from Early Drug Discovery to Development

11896.9 руб.
Detailing formulation approaches by stage of discovery to early development, this book gives a “playbook” of practical and efficient strategies to formulate drug candidates with the least chance of failing in clinical development. • Comes from contributing authors with experience developing formulations on the frontlines of the pharmaceutical industry • Focuses on pre (or non-) clinical and early stage development, the phases where most compounds are used in drug research • Features case studies to illustrate practical challenges and solutions in formulation selection • Covers regulatory filing, drug metabolism and physical and chemical properties, toxicology formulation, biopharmaceutics classification system (BCS), screening approaches, early stage clinical formulation development, and outsourcing
Oliver Koch Trypanosomatid Diseases. Molecular Routes to Drug Discovery Oliver Koch Trypanosomatid Diseases. Molecular Routes to Drug Discovery Новинка

Oliver Koch Trypanosomatid Diseases. Molecular Routes to Drug Discovery

13955.72 руб.
This is the first resource to provide researchers in academia and industry with an urgently needed update on drug intervention against trypanosomatides. As such, it covers every aspect of the topic from basic research findings, via current treatments to translational approaches in drug development and includes both human and livestock diseases. The outstanding editor and contributor team reads like a Who?s Who of the field, thus guaranteeing the outstanding quality of this ready reference.
Mike Lee S. Oral Bioavailability Assessment. Basics and Strategies for Drug Discovery and Development Mike Lee S. Oral Bioavailability Assessment. Basics and Strategies for Drug Discovery and Development Новинка

Mike Lee S. Oral Bioavailability Assessment. Basics and Strategies for Drug Discovery and Development

13879.71 руб.
Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability – one of the most significant hurdles in drug discovery and development. • Describes approaches to assess pharmacokinetics and how drug efflux and uptake transporters impact oral bioavailability • Helps readers reduce the failure rate of drug candidates when transitioning from the bench to the clinic during development • Explains how preclinical animal models – used in preclinical testing – and in vitro tools translate to humans, which is an underappreciated and complicated area of drug development • Includes chapters about pharmacokinetic modelling, the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the Extended Clearance Classification System (ECCS) • Has tutorials for applying strategies to medicinal chemistry practices of drug discovery/development
Wei Wang Biological Drug Products. Development and Strategies Wei Wang Biological Drug Products. Development and Strategies Новинка

Wei Wang Biological Drug Products. Development and Strategies

14831.62 руб.
Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Selzer Paul M. Parasitic Helminths. Targets, Screens, Drugs and Vaccines Selzer Paul M. Parasitic Helminths. Targets, Screens, Drugs and Vaccines Новинка

Selzer Paul M. Parasitic Helminths. Targets, Screens, Drugs and Vaccines

12803.24 руб.
This third volume in the successful 'Drug Discovery in Infectious Diseases' series is the first to deal with drug discovery in helminthic infections in human and animals. The result is a broad overview of different drug target evaluation methods, including specific examples of successful drug development against helminthes, and with a whole section devoted to vaccine development. With its well-balanced mix of high-profile contributors from academia and industry, this handbook and reference will appeal to a wide audience, including parasitologists, pharmaceutical industry, epidemiologists, and veterinary scientists.
Binghe Wang Evaluation of Drug Candidates for Preclinical Development. Pharmacokinetics, Metabolism, Pharmaceutics, and Toxicology Binghe Wang Evaluation of Drug Candidates for Preclinical Development. Pharmacokinetics, Metabolism, Pharmaceutics, and Toxicology Новинка

Binghe Wang Evaluation of Drug Candidates for Preclinical Development. Pharmacokinetics, Metabolism, Pharmaceutics, and Toxicology

10152.62 руб.
Emphasizes the integration of major areas of drug discovery and their importance in candidate evaluation It is believed that selecting the «right» drug candidate for development is the key to success. In the last decade, pharmaceutical R&D departments have integrated pharmacokinetics and drug metabolism, pharmaceutics, and toxicology into early drug discovery to improve the assessment of potential drug compounds. Now, Evaluation of Drug Candidates for Preclinical Development provides a complete view and understanding of why absorption-distribution-metabolism-excretion-toxicology (ADMET) plays a pivotal role in drug discovery and development. Encompassing the three major interrelated areas in which optimization and evaluation of drug developability is most critical—pharmacokinetics and drug metabolism, pharmaceutics, and safety assessment—this unique resource encourages integrated thinking in drug discovery. The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability issues that challenge pharma companies, moving beyond isolated experimental results Reveal connections between the key scientific areas that are critical for successful drug discovery and development Inspire forward-thinking strategies and decision-making processes in preclinical evaluation to maximize the potential of drug candidates to progress through development efficiently and meet the increasing demands of the marketplace Evaluation of Drug Candidates for Preclinical Development serves as an introductory reference for those new to the pharmaceutical industry and drug discovery in particular. It is especially well suited for scientists and management teams in small- to mid-sized pharmaceutical companies, as well as academic researchers and graduate students concerned with the practical aspects related to the evaluation of drug developability.
Li Chun Drug Delivery Applications of Noninvasive Imaging. Validation from Biodistribution to Sites of Action Li Chun Drug Delivery Applications of Noninvasive Imaging. Validation from Biodistribution to Sites of Action Новинка

Li Chun Drug Delivery Applications of Noninvasive Imaging. Validation from Biodistribution to Sites of Action

14087.97 руб.
Cost-effective strategies for designing novel drug delivery systems that target a broad range of disease conditions In vivo imaging has become an important tool for the development of new drug delivery systems, shedding new light on the pharmacokinetics, biodistribution, bioavailability, local concentration, and clearance of drug substances for the treatment of human disease, most notably cancer. Written by a team of international experts, this book examines the use of quantitative imaging techniques in designing and evaluating novel drug delivery systems and applications. Drug Delivery Applications of Noninvasive Imaging offers a full arsenal of tested and proven methods, practices and guidance, enabling readers to overcome the many challenges in creating successful new drug delivery systems. The book begins with an introduction to molecular imaging. Next, it covers: In vivo imaging techniques and quantitative analysis Imaging drugs and drug carriers at the site of action, including low-molecular weight radiopharmaceuticals, peptides and proteins, siRNA, cells, and nanoparticles Applications of imaging techniques in administration routes other than intravenous injection, such as pulmonary and oral delivery Translational research leading to clinical applications Imaging drug delivery in large animal models Clinical applications of imaging techniques to guide drug development and drug delivery Chapters are based on a thorough review of the current literature as well as the authors' firsthand experience working with imaging techniques for the development of novel drug delivery systems. Presenting state-of-the-technology applications of imaging in preclinical and clinical evaluation of drug delivery systems, Drug Delivery Applications of Noninvasive Imaging offers cost-effective strategies to pharmaceutical researchers and students for developing drug delivery systems that accurately target a broad range of disease conditions.
Guofeng You Drug Transporters. Molecular Characterization and Role in Drug Disposition Guofeng You Drug Transporters. Molecular Characterization and Role in Drug Disposition Новинка

Guofeng You Drug Transporters. Molecular Characterization and Role in Drug Disposition

14356.04 руб.
This new edition overviews drug transporters and presents the principles of drug transport and associated techniques, featuring new chapters on multidrug and toxin extrusion proteins, placental transport, in silico approaches in drug discovery, and regulatory guidance for drug transport studies in drug development. • Describes drug transporter families, mechanisms, and clinical implications along with experimental methods for studying and characterizing drug transporters • Includes new chapters on multidrug and toxin extrusion proteins, placental transport and in silico approaches in drug discovery • Has a new chapter covering regulatory guidance for the evaluation of drug transport in drug development with global criteria used for drug transporters in clinical trials • Arranges material to go from fundamental mechanisms to clinical outcomes, making the book useful for novice and expert readers
Natanya Civjan Chemical Biology. Approaches to Drug Discovery and Development to Targeting Disease Natanya Civjan Chemical Biology. Approaches to Drug Discovery and Development to Targeting Disease Новинка

Natanya Civjan Chemical Biology. Approaches to Drug Discovery and Development to Targeting Disease

10966.2 руб.
An authoritative look at the application of chemical biology in drug discovery and development Based on the award-winning Wiley Encyclopedia of Chemical Biology published in 2008, this book explores the role of chemical biology in drug discovery and development. The first part of the book reviews key principles and techniques used in the design and evaluation of drug candidates. The second part elucidates biological mechanisms of certain diseases, illuminating approaches to investigate and target these diseases. Comprising carefully selected reprints from the Encyclopedia as well as new contributions from leading scholars in the field, this book provides researchers in academia and industry with important information to aid in the development of novel agents to treat disease. Self-contained articles cover a variety of essential topics, including: The design, development, and optimization of drug candidates The pharmacokinetics and properties of drugs Drug transport and delivery Natural products and natural product models as pharmaceuticals Biological mechanisms underlying health and disease Treatment strategies for a range of diseases, from HIV to schizophrenia Chemical Biology is a top-notch guide and reference for anyone working in the areas of drug discovery and development, including researchers in chemical biology and other fields such as biochemistry, medicine, and pharmaceutical sciences.
Urban Laszlo Predictive ADMET. Integrated Approaches in Drug Discovery and Development Urban Laszlo Predictive ADMET. Integrated Approaches in Drug Discovery and Development Новинка

Urban Laszlo Predictive ADMET. Integrated Approaches in Drug Discovery and Development

12407.02 руб.
This book helps readers integrate in silico, in vitro, and in vivo ADMET (absorption, distribution, metabolism, elimination and toxicity) and PK (pharmacokinetics) data with routine testing applications so that pharmaceutical scientists can diagnose ADMET problems and present appropriate recommendations to move drug discovery programs forward. The book introduces the current clinical practice for drug discovery and development along with the impact on early risk assessment; consolidates the tools and models to intelligently integrate existing in silico, in vitro and in vivo ADMET data; and demonstrates successful cases and lessons learned from real drug discovery and development. In short, it is a book aimed to provide a practical road map for drug discovery and development scientists to generate efficacious and safe drugs for unmet medical needs.
Rossi John J. RNA Interference. Application to Drug Discovery and Challenges to Pharmaceutical Development Rossi John J. RNA Interference. Application to Drug Discovery and Challenges to Pharmaceutical Development Новинка

Rossi John J. RNA Interference. Application to Drug Discovery and Challenges to Pharmaceutical Development

11126.29 руб.
RNA Interference: Application to Drug Discovery and Challenges to Pharmaceutical Development provides a general overview of this rapidly emerging field, with a strong emphasis on issues and aspects that are important to a drug development team. The first part covers more general background of RNA interference and its application in drug discovery. In the second part, the book addresses siRNA (small interfering RNA), a pharmaceutically potent form, and its use and delivery in therapeutics along with manufacturing and delivery aspects.
Claudio Carini Biomarkers in Drug Development. A Handbook of Practice, Application, and Strategy Claudio Carini Biomarkers in Drug Development. A Handbook of Practice, Application, and Strategy Новинка

Claudio Carini Biomarkers in Drug Development. A Handbook of Practice, Application, and Strategy

16180.08 руб.
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Ganellin C. Robin Analogue-based Drug Discovery II Ganellin C. Robin Analogue-based Drug Discovery II Новинка

Ganellin C. Robin Analogue-based Drug Discovery II

18970.73 руб.
Born out of a project of the IUPAC's committee on Medicinal Chemistry and Drug Development, this reference addresses past and current strategies for successful drug analog development, extending the previously published volume by nine new analog classes and eight case studies. Like its precursor, this volume also contains a general section discussing universally applicable strategies for analog discovery and development. Spanning a wide range of therapeutic fields and chemical classes, the two volumes together constitute the first systematic approach to drug analog development. Of interest to virtually every researcher working in drug discovery and pharmaceutical chemistry.
Zhou Honghui Drug-Drug Interactions for Therapeutic Biologics Zhou Honghui Drug-Drug Interactions for Therapeutic Biologics Новинка

Zhou Honghui Drug-Drug Interactions for Therapeutic Biologics

10646.02 руб.
Strategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics.
Gerhard Friedrich Müller Protein Kinases as Drug Targets Gerhard Friedrich Müller Protein Kinases as Drug Targets Новинка

Gerhard Friedrich Müller Protein Kinases as Drug Targets

15466.72 руб.
This timely guide to kinase inhibitor drug development is the first to cover the entire drug pipeline, from target identification to compound development and clinical application. Edited by the pioneers in the field, on the drug development side this ready reference discusses classical medicinal chemistry approaches as well as current chemical genomics strategies. On the clinical side, both current and future therapeutic application areas for kinase inhibitor drugs are addressed, with a strong focus on oncology drugs. Backed by recent clinical experience with first-generation drugs in the battle against various forms of cancer, this is crucial reading for medicinal, pharmaceutical and biochemists, molecular biologists, and oncologists, as well as those working in the pharmaceutical industry.
Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation Новинка

Richard Kay Statistical Thinking for Non-Statisticians in Drug Regulation

8240.66 руб.
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.
Young Daniel L. Systems Biology in Drug Discovery and Development Young Daniel L. Systems Biology in Drug Discovery and Development Новинка

Young Daniel L. Systems Biology in Drug Discovery and Development

10165.75 руб.
The first book to focus on comprehensive systems biology as applied to drug discovery and development Drawing on real-life examples, Systems Biology in Drug Discovery and Development presents practical applications of systems biology to the multiple phases of drug discovery and development. This book explains how the integration of knowledge from multiple sources, and the models that best represent that integration, inform the drug research processes that are most relevant to the pharmaceutical and biotechnology industries. The first book to focus on comprehensive systems biology and its applications in drug discovery and development, it offers comprehensive and multidisciplinary coverage of all phases of discovery and design, including target identification and validation, lead identification and optimization, and clinical trial design and execution, as well as the complementary systems approaches that make these processes more efficient. It also provides models for applying systems biology to pharmacokinetics, pharmacodynamics, and candidate biomarker identification. Introducing and explaining key methods and technical approaches to the use of comprehensive systems biology on drug development, the book addresses the challenges currently facing the pharmaceutical industry. As a result, it is essential reading for pharmaceutical and biotech scientists, pharmacologists, computational modelers, bioinformaticians, and graduate students in systems biology, pharmaceutical science, and other related fields.
Elizabeth Votruba-Drzal The Wiley Handbook of Early Childhood Development Programs, Practices, and Policies Elizabeth Votruba-Drzal The Wiley Handbook of Early Childhood Development Programs, Practices, and Policies Новинка

Elizabeth Votruba-Drzal The Wiley Handbook of Early Childhood Development Programs, Practices, and Policies

15466.72 руб.
The first and only comprehensive review of current early childhood development theory, practices, policies, and the science behind them This unique and important bookprovides a comprehensive overview of the current theory, practices, and policies in early childhood development withinthe contexts of family, school, and community, and society at large. Moreover, it synthesizes scientifically rigorous research from an array of disciplines in an effort to identify the most effective strategies for promoting early childhood development. Research into childhood development is booming, and the scientific knowledge base concerning early childhood development is now greater than that of any other stage of the human life span. At the same time, efforts to apply that knowledge to early childhood practices, programs, and policies have never been greater or more urgent. Yet, surprisingly, until The Handbook of Early Childhood Development Programs, Practices, and Policies, there was no comprehensive, critical review of the applied science in the field. The book begins with in-depth coverage of child and family approaches. From there it moves onto a consideration of school- and community-based strategies. It concludes with a discussion of current social policies on health and development in early childhood and their implications. Provides a comprehensive overview of the state of the knowledge base, along with guidance for the future of the field Examines the underlying theory and basic science guiding efforts to promote early childhood development Critically reviews the strength of the empirical support for individual practices, programs, and policies Explores key opportunities and barriers policymakers and practitioners face when implementing various approaches Pays particular attention to socioeconomically disadvantaged and other disenfranchised populations The Handbook of Early Childhood Development Programs, Practices, and Policies is a valuable resource for practitioners, scholars, graduate students, and advanced undergraduate students across the social sciences who are interested in strengthening their understanding of current strategies for promoting early childhood development and the science informing those strategies.
Toshihisa Ishikawa Pharmacogenomics of Human Drug Transporters. Clinical Impacts Toshihisa Ishikawa Pharmacogenomics of Human Drug Transporters. Clinical Impacts Новинка

Toshihisa Ishikawa Pharmacogenomics of Human Drug Transporters. Clinical Impacts

12690.78 руб.
Sets the foundation for safer, more effective drug therapies With this book as their guide, readers will discover how to apply our current understanding of the pharmacogenomics of drug transporters to advance their own drug discovery and development efforts. In particular, the book explains how new findings in the field now enable researchers to more accurately predict drug interactions and adverse drug reactions. Moreover, it sets the foundation for the development of drug therapies that are tailored to an individual patient's genetics. Pharmacogenomics of Human Drug Transporters serves as a comprehensive guide to how transporters regulate the absorption, distribution, and elimination of drugs in the body as well as how an individual's genome affects those processes. The book's eighteen chapters have been authored by a team of leading pioneers in the field. Based on their own laboratory and clinical experience as well as a thorough review of the literature, these authors explore all facets of drug transporter pharmacogenomics, including: Individual drug transporters and transporter families and their clinical significance Principles of altered drug transport in drug–drug interactions, pharmacotherapy, and personalized medicine Emerging new technologies for rapid detection of genetic polymorphisms Clinical aspects of genetic polymorphisms in major drug transporter genes Future research directions of drug transporter pharmacogenomics and the prospect of individualized medicine Pharmacogenomics of Human Drug Transporters opens the door to new drug discovery and development breakthroughs leading to safer and more effective customized drug therapies.The book is recommended for pharmaceutical scientists, biochemists, pharmacologists, clinicians, and genetics and genomics researchers.
N. Balakrishnan Methods and Applications of Statistics in Clinical Trials, Volume 1. Concepts, Principles, Trials, and Designs N. Balakrishnan Methods and Applications of Statistics in Clinical Trials, Volume 1. Concepts, Principles, Trials, and Designs Новинка

N. Balakrishnan Methods and Applications of Statistics in Clinical Trials, Volume 1. Concepts, Principles, Trials, and Designs

16413.36 руб.
A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results. The referenceunveils modern approaches vital to understanding, creating, and evaluating data obtained throughoutthe various stages of clinical trial design and analysis. Accessible and comprehensive, the first volume in a two-part set includes newly-written articles as well as established literature from the Wiley Encyclopedia of Clinical Trials. Illustrating a variety of statistical concepts and principles such as longitudinal data, missing data, covariates, biased-coin randomization, repeated measurements, and simple randomization, the book also provides in-depth coverage of the various trial designs found within phase I-IV trials. Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs also features: Detailed chapters on the type of trial designs, such as adaptive, crossover, group-randomized, multicenter, non-inferiority, non-randomized, open-labeled, preference, prevention, and superiority trials Over 100 contributions from leading academics, researchers, and practitioners An exploration of ongoing, cutting-edge clinical trials on early cancer and heart disease, mother-to-child human immunodeficiency virus transmission trials, and the AIDS Clinical Trials Group Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs is an excellent reference for researchers, practitioners, and students in the fields of clinicaltrials, pharmaceutics, biostatistics, medical research design, biology, biomedicine, epidemiology,and public health.
Michael Brown A. A History of a cGMP Medical Event Investigation Michael Brown A. A History of a cGMP Medical Event Investigation Новинка

Michael Brown A. A History of a cGMP Medical Event Investigation

3644.32 руб.
Case study details the right way and the wrong way to successfully develop and market a new drug Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization. From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including: FDA Investigational and New Drug Application Processes FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP) ISPE Good Automated Manufacturing Practice (GAMP) Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments. A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.
Lu Chuang Enzyme Inhibition in Drug Discovery and Development. The Good and the Bad Lu Chuang Enzyme Inhibition in Drug Discovery and Development. The Good and the Bad Новинка

Lu Chuang Enzyme Inhibition in Drug Discovery and Development. The Good and the Bad

17926.14 руб.
The science and applied approaches of enzyme inhibition in drug discovery and development Offering a unique approach that includes both the pharmacologic and pharmaco-kinetic aspects of enzyme inhibition, Enzyme Inhibition in Drug Discovery and Development examines the scientific concepts and experimental approaches related to enzyme inhibition as applied in drug discovery and drug development. With chapters written by over fifty leading experts in their fields, Enzyme Inhibition in Drug Discovery and Development fosters a cross-fertilization of pharmacology, drug metabolism, pharmacokinetics, and toxicology by understanding the «good» inhibitions—desirable pharmacological effects—and «bad» inhibitions—drug–drug interactions and toxicity. The book discusses: The drug discovery process, including drug discovery strategy, medicinal chemistry, analytical chemistry, drug metabolism, pharmacokinetics, and safety biomarker assessment The manipulations of drug metabolizing enzymes and transporters as well as the negative consequences, such as drug–drug interactions The inhibition of several major drug target pathways, such as the GPCR pathway, the NFkB pathway, and the ion channel pathway Through this focused, single-source reference on the fundamentals of drug discovery and development, researchers in drug metabolism and pharmacokinetics (DMPK) will learn and appreciate target biology in drug discovery; discovery biologists and medicinal chemists will also broaden their understanding of DMPK.
Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies Новинка

Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies

12246.93 руб.
This book provides a comprehensive overview of the development of metabolic syndrome, the underlying mechanisms and therapeutic strategies for drug development. The authors examine the context of underlying molecular pathways and integrated physiology, then expanding the discussion to diseases associated with metabolic syndrome. The development of drug therapies for these diseases and complications is extensively covered. The book offers a comprehensive and in-depth view of energy metabolism, metabolic tissues and pathways, molecular mechanism-based drug discovery and clinical implications.
Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies Новинка

Minghan Wang Metabolic Syndrome. Underlying Mechanisms and Drug Therapies

12135.44 руб.
This book provides a comprehensive overview of the development of metabolic syndrome, the underlying mechanisms and therapeutic strategies for drug development. The authors examine the context of underlying molecular pathways and integrated physiology, then expanding the discussion to diseases associated with metabolic syndrome. The development of drug therapies for these diseases and complications is extensively covered. The book offers a comprehensive and in-depth view of energy metabolism, metabolic tissues and pathways, molecular mechanism-based drug discovery and clinical implications.
Litwin Virginia Flow Cytometry in Drug Discovery and Development Litwin Virginia Flow Cytometry in Drug Discovery and Development Новинка

Litwin Virginia Flow Cytometry in Drug Discovery and Development

11126.29 руб.
This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.
Whitehouse David Molecular and Cellular Therapeutics Whitehouse David Molecular and Cellular Therapeutics Новинка

Whitehouse David Molecular and Cellular Therapeutics

8881.02 руб.
Molecular and Cellular Therapeutics aims to bring together key developments in the areas of molecular diagnostics, therapeutics and drug discovery. The book covers topics including diagnostics, therapeutics, model systems, clinical trials and drug discovery. The developing approaches to molecular and cellular therapies, diagnostics and drug discovery are presented in the context of the pathologies they are devised to treat.
Hugo Kubinyi Prodrugs and Targeted Delivery. Towards Better ADME Properties Hugo Kubinyi Prodrugs and Targeted Delivery. Towards Better ADME Properties Новинка

Hugo Kubinyi Prodrugs and Targeted Delivery. Towards Better ADME Properties

16655.66 руб.
This topical reference and handbook addresses the chemistry, pharmacology, toxicology and the patentability of prodrugs, perfectly mirroring the integrated approach prevalent in today's drug design. It summarizes current experiences and strategies for the rational design of prodrugs, beginning at the early stages of the development process, as well as discussing organ- and site-selective prodrugs. Every company employing medicinal chemists will be interested in this practice-oriented overview of a key strategy in modern drug discovery and development.
Daniele Martini De Success Probability Estimation with Applications to Clinical Trials Daniele Martini De Success Probability Estimation with Applications to Clinical Trials Новинка

Daniele Martini De Success Probability Estimation with Applications to Clinical Trials

7684.35 руб.
Provides an introduction to the various statistical techniques involved in medical research and drug development with a focus on estimating the success probability of an experiment Success Probability Estimation with Applications to Clinical Trials details the use of success probability estimation in both the planning and analyzing of clinical trials and in widely used statistical tests. Devoted to both statisticians and non-statisticians who are involved in clinical trials, Part I of the book presents new concepts related to success probability estimation and their usefulness in clinical trials, and each section begins with a non-technical explanation of the presented concepts. Part II delves deeper into the techniques for success probability estimation and features applications to both reproducibility probability estimation and conservative sample size estimation. Success Probability Estimation with Applications to Clinical Trials: • Addresses the theoretical and practical aspects of the topic and introduces new and promising techniques in the statistical and pharmaceutical industries Features practical solutions for problems that are often encountered in clinical trials Includes success probability estimation for widely used statistical tests, such as parametric and nonparametric models Focuses on experimental planning, specifically the sample size of clinical trials using phase II results and data for planning phase III trials Introduces statistical concepts related to success probability estimation and their usefulness in clinical trials Success Probability Estimation with Applications to Clinical Trials is an ideal reference for statisticians and biostatisticians in the pharmaceutical industry as well as researchers and practitioners in medical centers who are actively involved in health policy, clinical research, and the design and evaluation of clinical trials.
Huang Xianhai Case Studies in Modern Drug Discovery and Development Huang Xianhai Case Studies in Modern Drug Discovery and Development Новинка

Huang Xianhai Case Studies in Modern Drug Discovery and Development

12006.79 руб.
Learn why some drug discovery and development efforts succeed . . . and others fail Written by international experts in drug discovery and development, this book sets forth carefully researched and analyzed case studies of both successful and failed drug discovery and development efforts, enabling medicinal chemists and pharmaceutical scientists to learn from actual examples. Each case study focuses on a particular drug and therapeutic target, guiding readers through the drug discovery and development process, including drug design rationale, structure-activity relationships, pharmacology, drug metabolism, biology, and clinical studies. Case Studies in Modern Drug Discovery and Development begins with an introductory chapter that puts into perspective the underlying issues facing the pharmaceutical industry and provides insight into future research opportunities. Next, there are fourteen detailed case studies, examining: All phases of drug discovery and development from initial idea to commercialization Some of today's most important and life-saving medications Drugs designed for different therapeutic areas such as cardiovascular disease, infection, inflammation, cancer, metabolic syndrome, and allergies Examples of prodrugs and inhaled drugs Reasons why certain drugs failed to advance to market despite major research investments Each chapter ends with a list of references leading to the primary literature. There are also plenty of tables and illustrations to help readers fully understand key concepts, processes, and technologies. Improving the success rate of the drug discovery and development process is paramount to the pharmaceutical industry. With this book as their guide, readers can learn from both successful and unsuccessful efforts in order to apply tested and proven science and technologies that increase the probability of success for new drug discovery and development projects.
Kim Ekroos Lipidomics. Technologies and Applications Kim Ekroos Lipidomics. Technologies and Applications Новинка

Kim Ekroos Lipidomics. Technologies and Applications

10707.96 руб.
Focusing on the practical applications, this user-oriented guide presents current technologies and strategies for systems-level lipid analysis, going beyond basic research to concentrate on commercial uses of lipidomics in biomarker and diagnostic development, as well as within pharmaceutical drug discovery and development. The editor and authors have experience of the most recent analytical instruments and techniques, allowing them to provide here first-hand practical experience for newcomers to the field. The first half of the book covers current methodologies, ranging from global to targeted lipidomics and shotgun approaches, while the second part discusses the role of lipidomics in biomedical and pharmaceutical research, covering such diverse fields as inflammation, metabolic syndrome, cardiovascular and neurological disease. Both small and large-scale, high-throughput approaches are discussed, resulting in an invaluable source for academic and industrial research and development.
Hedley Rees Supply Chain Management in the Drug Industry. Delivering Patient Value for Pharmaceuticals and Biologics Hedley Rees Supply Chain Management in the Drug Industry. Delivering Patient Value for Pharmaceuticals and Biologics Новинка

Hedley Rees Supply Chain Management in the Drug Industry. Delivering Patient Value for Pharmaceuticals and Biologics

9281.25 руб.
This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
Yoon Yeo Nanoparticulate Drug Delivery Systems. Strategies, Technologies, and Applications Yoon Yeo Nanoparticulate Drug Delivery Systems. Strategies, Technologies, and Applications Новинка

Yoon Yeo Nanoparticulate Drug Delivery Systems. Strategies, Technologies, and Applications

12690.78 руб.
Frank discussions of opportunities and challenges point the way to new, more effective drug delivery systems Interest in nanomedicine has grown tremendously, fueled by the expectation that continued research will lead to the safe, efficient, and cost-effective delivery of drugs or imaging agents to human tissues and organs. The field, however, has faced several challenges attempting to translate novel ideas into clinical benefits. With contributions from an international team of leading nanomedicine researchers, this book provides a practical assessment of the possibilities and the challenges of modern nanomedicine that will enable the development of clinically effective nanoparticulate drug delivery products and systems. Nanoparticulate Drug Delivery Systems focuses on the rationales and preclinical evaluation of new nanoparticulate drug carriers that have yet to be thoroughly reviewed in the literature. The first chapter sets the stage with a general overview of targeted nanomedicine. The book then explores new and promising nanoparticulate drug delivery systems, including: Lipid nanoparticles for the delivery of nucleic acids Multifunctional dendritic nanocarriers Polymer drug nanoconjugates Next, the book presents new opportunities and challenges for nanoparticulate drug delivery systems, including: Clearance of nanoparticles during circulation Drug delivery strategies for combatting multiple drug resistance Toxicological assessment of nanomedicine Chapters offer state-of-the-technology reviews with extensive references to facilitate further investigation. Moreover, each chapter concludes with an expert assessment of remaining challenges, pointing the way to solutions and new avenues of research. With its frank discussions of opportunities and challenges, Nanoparticulate Drug Delivery Systems sets a solid foundation for new research leading to the discovery and development of better nanomedicines.
Barratt Michael J. Drug Repositioning. Bringing New Life to Shelved Assets and Existing Drugs Barratt Michael J. Drug Repositioning. Bringing New Life to Shelved Assets and Existing Drugs Новинка

Barratt Michael J. Drug Repositioning. Bringing New Life to Shelved Assets and Existing Drugs

10966.2 руб.
The how's and why's of successful drug repositioning Drug repositioning, also known as drug reprofiling or repurposing, has become an increasingly important part of the drug development process. This book examines the business, technical, scientific, and operational challenges and opportunities that drug repositioning offers. Readers will learn how to perform the latest experimental and computational methods that support drug repositioning, and detailed case studies throughout the book demonstrate how these methods fit within the context of a comprehensive drug repositioning strategy. Drug Repositioning is divided into three parts: Part 1, Drug Repositioning: Business Case, Strategies, and Operational Considerations, examines the medical and commercial drivers underpinning the quest to reposition existing drugs, guiding readers through the key strategic, technical, operational, and regulatory decisions needed for successful drug repositioning programs. Part 2, Application of Technology Platforms to Uncover New Indications and Repurpose Existing Drugs, sets forth computational-based strategies, tools, and databases that have been designed for repositioning studies, screening approaches, including combinations of existing drugs, and a look at the development of chemically modified analogs of approved agents. Part 3, Academic and Non-Profit Initiatives & the Role of Alliances in the Drug Repositioning Industry, explores current investigations for repositioning drugs to treat rare and neglected diseases, which are frequently overlooked by for-profit pharmaceutical companies due to their lack of commercial return. The book's appendix provides valuable resources for drug repositioning researchers, including information on drug repositioning and reformulation companies, databases, government resources and organizations, regulatory agencies, and drug repositioning initiatives from academia and non-profits. With this book as their guide, students and pharmaceutical researchers can learn how to use drug repositioning techniques to extend the lifespan and applications of existing drugs as well as maximize the return on investment in drug research and development.
Hugo Kubinyi Drug Metabolism Prediction Hugo Kubinyi Drug Metabolism Prediction Новинка

Hugo Kubinyi Drug Metabolism Prediction

16259.09 руб.
The first professional reference on this highly relevant topic, for drug developers, pharmacologists and toxicologists. The authors provide more than a systematic overview of computational tools and knowledge bases for drug metabolism research and their underlying principles. They aim to convey their expert knowledge distilled from many years of experience in the field. In addition to the fundamentals, computational approaches and their applications, this volume provides expert accounts of the latest experimental methods for investigating drug metabolism in four dedicated chapters. The authors discuss the most important caveats and common errors to consider when working with experimental data. Collating the knowledge gained over the past decade, this practice-oriented guide presents methods not only used in drug development, but also in the development and toxicological assessment of cosmetics, functional foods, agrochemicals, and additives for consumer goods, making it an invaluable reference in a variety of disciplines.
Peter Bellwood First Islanders. Prehistory and Human Migration in Island Southeast Asia Peter Bellwood First Islanders. Prehistory and Human Migration in Island Southeast Asia Новинка

Peter Bellwood First Islanders. Prehistory and Human Migration in Island Southeast Asia

7530.94 руб.
Incorporating research findings over the last twenty years, First Islanders examines the human prehistory of Island Southeast Asia. This fascinating story is explored from a broad swathe of multidisciplinary perspectives and pays close attention to migration in the period dating from 1.5 million years ago to the development of Indic kingdoms late in the first millennium CE.
Karen Lackey Medicinal Chemistry Approaches to Personalized Medicine Karen Lackey Medicinal Chemistry Approaches to Personalized Medicine Новинка

Karen Lackey Medicinal Chemistry Approaches to Personalized Medicine

15545.73 руб.
Edited by two renowned medicinal chemists who have pioneered the development of personalized therapies in their respective fields, this authoritative analysis of what is already possible is the first of its kind, and the only one to focus on drug development issues. Numerous case studies from the first generation of «personalized drugs» are presented, highlighting the challenges and opportunities for pharmaceutical development. While the majority of these examples are taken from the field of cancer treatment, other key emerging areas, such as neurosciences and inflammation, are also covered. With its careful balance of current and future approaches, this handbook is a prime knowledge source for every drug developer, and one that will remain up to date for some time to come. From the content: * Discovery of Predictive Biomarkers for Anticancer Drugs * Discovery and Development of Vemurafenib * Targeting Basal-Cell Carcinoma * G-Quadruplexes as Therapeutic Targets in Cancer * From Human Genetics to Drug Candidates: An Industrial Perspective on LRRK2 Inhibition as a Treatment for Parkinson's Disease * Therapeutic Potential of Kinases in Asthma * DNA Damage Repair Pathways and Synthetic Lethality * Medicinal Chemistry in the Context of the Human Genome and many more
Souzan Yanni B. Translational ADMET for Drug Therapy. Principles, Methods, and Pharmaceutical Applications Souzan Yanni B. Translational ADMET for Drug Therapy. Principles, Methods, and Pharmaceutical Applications Новинка

Souzan Yanni B. Translational ADMET for Drug Therapy. Principles, Methods, and Pharmaceutical Applications

10707.96 руб.
Serving as a practical handbook about ADMET for drug therapy, this book presents effective technologies, methods, applications, data interpretation, and decision-making tactics for pharmaceutical and preclinical scientists. Chapters cover case studies and in vivo, in vitro, and computational tools for drug discovery and development, with new translational approaches to clinical drug investigations in various human populations. Illustrates ADME properties, from bedside to bench and bench to bedside, for the design of safe and effective medicine in human populations Provides examples that demonstrate the integration of in vitro, in vivo, and in silico data to address human PKPD and TKTD and help determine the proper therapeutic dosage Presents successful tools for evaluating drugs and covers current translational ADMET with regulatory guidelines Offers a hands-on manual for researchers and scientists to design and execute in vitro, in silico, preclinical, and clinical studies Includes discussion of IND / NDA filing and drug labeling to support drug registration and approval
Edward D. Zanders Human Drug Targets. A Compendium for Pharmaceutical Discovery Edward D. Zanders Human Drug Targets. A Compendium for Pharmaceutical Discovery Новинка

Edward D. Zanders Human Drug Targets. A Compendium for Pharmaceutical Discovery

11896.9 руб.
The identification of drug targets in a given disease has been central to pharmaceutical research from the latter half of the 20th century right up to the modern genomics era. Human Drug Targets provides an essential guide to one of the most important aspects of drug discovery – the identification of suitable protein and RNA targets prior to the creation of drug development candidates. The first part of the book consists of introductory chapters that provide the background to drug target discovery and highlight the way in which these targets have been organised into online databases. It also includes a user’s guide to the list of entries that forms the bulk of the book. Since this is not designed to be a compendium of drugs, the emphasis will be on the known (or speculated) biological role of the targets and not on the issues associated with pharmaceutical development. The objective is to provide just enough information to be informative and prompt further searches, while keeping the amount of text for each of the many entries to a minimum. Human Drug Targets will prove invaluable to those drug discovery professionals, in both industry and academia, who need to make some sense of the bewildering array of online information sources on current and potential human drug targets. As well as creating order out of a complex target landscape, the book will act as an ideas generator for potentially novel targets that might form the basis of future discovery projects.
Surapaneni Sekhar ADME-Enabling Technologies in Drug Design and Development Surapaneni Sekhar ADME-Enabling Technologies in Drug Design and Development Новинка

Surapaneni Sekhar ADME-Enabling Technologies in Drug Design and Development

15368.69 руб.
A comprehensive guide to cutting-edge tools in ADME research The last decade has seen tremendous progress in the development of analytical techniques such as mass spectrometry and molecular biology tools, resulting in important advances in drug discovery, particularly in the area of absorption, distribution, metabolism, and excretion (ADME). ADME-Enabling Technologies in Drug Design and Development focuses on the current state of the art in the field, presenting a comprehensive review of the latest tools for generating ADME data in drug discovery. It examines the broadest possible range of available technologies, giving readers the information they need to choose the right tool for a given application, a key requisite for obtaining favorable results in a timely fashion for regulatory filings. With over thirty contributed chapters by an international team of experts, the book provides: A thorough examination of current tools, covering both electronic/mechanical technologies and biologically based ones Coverage of applications for each technology, including key parameters, optimal conditions for intended results, protocols, and case studies Detailed discussion of emerging tools and techniques, from stem cells and genetically modified animal models to imaging technologies Numerous figures and diagrams throughout the text Scientists and researchers in drug metabolism, pharmacology, medicinal chemistry, pharmaceutics, toxicology, and bioanalytical science will find ADME-Enabling Technologies in Drug Design and Development an invaluable guide to the entire drug development process, from discovery to regulatory issues.
Josse Thomas R. Global New Drug Development. An Introduction Josse Thomas R. Global New Drug Development. An Introduction Новинка

Josse Thomas R. Global New Drug Development. An Introduction

10306.88 руб.
The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. “This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University…. I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book.. (and, therefore)… this book could not be more timely. “ Professor Mike Coleman, University of Aston., UK ( from his review of the final manuscript)
Castanho Miguel Peptide Drug Discovery and Development. Translational Research in Academia and Industry Castanho Miguel Peptide Drug Discovery and Development. Translational Research in Academia and Industry Новинка

Castanho Miguel Peptide Drug Discovery and Development. Translational Research in Academia and Industry

16569.37 руб.
Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the «bench to bedside» translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.
Kun Cheng Advanced Drug Delivery Kun Cheng Advanced Drug Delivery Новинка

Kun Cheng Advanced Drug Delivery

10231.63 руб.
Provides both fundamentals and new and emerging applications Advanced Drug Delivery brings readers fully up to date with the state of the science, presenting the basics, formulation strategies, and therapeutic applications of advanced drug delivery. The book demonstrates how core concepts of pharmaceutical sciences, chemistry, and molecular biology can be combined and applied in order to spark novel ideas to design and develop advanced drug delivery systems for the treatment of a broad range of human diseases. Advanced Drug Delivery features contributions from an international team of pharmaceutical scientists. Chapters reflect a thorough review and analysis of the literature as well as the authors' firsthand experience developing drug delivery systems. The book is divided into four parts: Part I, Introduction and Basics of Advanced Drug Delivery, explores physiological barriers, stability, transporters, and biomaterials in drug delivery Part II, Strategies for Advanced Drug Delivery, offers tested and proven strategies for advanced delivery of both small molecules and macromolecules Part III, Translational Research of Advanced Drug Delivery, focuses on regulatory considerations and translational applications of advanced drug delivery systems for the treatment of cardiovascular diseases, cancer, sexually transmitted diseases, ophthalmic diseases, and brain diseases Part IV, Future Applications of Advanced Drug Delivery in Emerging Research Areas, examines stem cell research, cell-based therapeutics, tissue engineering, and molecular imaging Each chapter provides objectives and assessment questions to help readers grasp key concepts and assess their knowledge as they progress through the book. Advanced Drug Delivery is recommended for graduates and upper-level undergraduates in the pharmaceutical sciences who need a solid foundation in the basics. It is also recommended for pharmaceutical professionals who want to take advantage of new and emerging applications in advanced drug delivery systems.
Dionysios Douroumis Drug Delivery Strategies for Poorly Water-Soluble Drugs Dionysios Douroumis Drug Delivery Strategies for Poorly Water-Soluble Drugs Новинка

Dionysios Douroumis Drug Delivery Strategies for Poorly Water-Soluble Drugs

15624.74 руб.
Many newly proposed drugs suffer from poor water solubility, thus presenting major hurdles in the design of suitable formulations for administration to patients. Consequently, the development of techniques and materials to overcome these hurdles is a major area of research in pharmaceutical companies. Drug Delivery Strategies for Poorly Water-Soluble Drugs provides a comprehensive overview of currently used formulation strategies for hydrophobic drugs, including liposome formulation, cyclodextrin drug carriers, solid lipid nanoparticles, polymeric drug encapsulation delivery systems, self–microemulsifying drug delivery systems, nanocrystals, hydrosol colloidal dispersions, microemulsions, solid dispersions, cosolvent use, dendrimers, polymer- drug conjugates, polymeric micelles, and mesoporous silica nanoparticles. For each approach the book discusses the main instrumentation, operation principles and theoretical background, with a focus on critical formulation features and clinical studies. Finally, the book includes some recent and novel applications, scale-up considerations and regulatory issues. Drug Delivery Strategies for Poorly Water-Soluble Drugs is an essential multidisciplinary guide to this important area of drug formulation for researchers in industry and academia working in drug delivery, polymers and biomaterials.
Tsaioun Katya ADMET for Medicinal Chemists. A Practical Guide Tsaioun Katya ADMET for Medicinal Chemists. A Practical Guide Новинка

Tsaioun Katya ADMET for Medicinal Chemists. A Practical Guide

12246.93 руб.
This book guides medicinal chemists in how to implement early ADMET testing in their workflow in order to improve both the speed and efficiency of their efforts. Although many pharmaceutical companies have dedicated groups directly interfacing with drug discovery, the scientific principles and strategies are practiced in a variety of different ways. This book answers the need to regularize the drug discovery interface; it defines and reviews the field of ADME for medicinal chemists. In addition, the scientific principles and the tools utilized by ADME scientists in a discovery setting, as applied to medicinal chemistry and structure modification to improve drug-like properties of drug candidates, are examined.
Ekins Sean The Agile Approach to Adaptive Research. Optimizing Efficiency in Clinical Development Ekins Sean The Agile Approach to Adaptive Research. Optimizing Efficiency in Clinical Development Новинка

Ekins Sean The Agile Approach to Adaptive Research. Optimizing Efficiency in Clinical Development

7760.39 руб.
Apply adaptive research to improve results in drug development The pharmaceutical industry today faces a deepening crisis: inefficiency in its core business, the development of new drugs. The Agile Approach to Adaptive Research offers a solution. It outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently. With a wealth of real-world cases and examples, author Michael Rosenberg gives readers a practical overview of drug development, the problems inherent in current practices, and the advantages of adaptive research technology and methods. He explains the concepts, principles, and specific techniques of adaptive research, and demonstrates why it is an essential evolutionary step toward improving drug research and development. Chapters explore such subjects as: The adaptive concept Design and operational adaptations Sample-size reestimation Agile clinical development Safety and dose finding Statistics in adaptive research, including frequentist and Bayesian approaches Data management technologies The future of clinical development By combining centuries-old intellectual foundations, recent technological advances, and modern management techniques, adaptive research preserves the integrity and validity of clinical research but dramatically improves efficiency.
Heide Schatten Human Reproduction. Updates and New Horizons Heide Schatten Human Reproduction. Updates and New Horizons Новинка

Heide Schatten Human Reproduction. Updates and New Horizons

15862.53 руб.
In vitro fertilization (IVF) and other assisted reproductive technologies (ART) have become a significant part of human reproduction, with already one in 50 children worldwide being born through ART and the demand steadily increasing. To accommodate the various kinds of infertility problems, new methods have been developed to increase IVF and ART success rates and it has also become possible to treat sperm, eggs, and embryos in culture to improve reproductive success, to increase the health state of an embryo, and to prevent disease in the developing child. Human Reproduction: Updates and New Horizons focuses on recent developments and new approaches to study egg and sperm cells and embryo development, as well as addressing the increasing demand for IVF and ART to overcome infertility problems of various kinds that are encountered by an increasing number of couples worldwide. The book includes 10 chapters written by experts in their specific fields to provide information on sperm selection techniques and their relevance to ART; In vitro maturation of human oocytes: current practices and future promises; Molecular biology of endometriosis; Novel immunological aspects for the treatment of age-induced ovarian and testicular infertility, other functional diseases, and early and advanced cancer immunotherapy; Mitochondrial manipulation for infertility treatment and disease prevention; Novel imaging techniques to assess gametes and preimplantation embryos; Clinical application of methods to select in vitro fertilized embryos; New horizons/developments in time-lapse morphokinetic analysis of mammalian embryos; The non-human primate model for early human development; Cytoskeletal functions, defects, and dysfunctions affecting human fertilization and embryo development. This book will appeal to a large interdisciplinary audience, including researchers from both the basic science and medical communities. It will be a valuable reference for IVF clinicians, patients and prospective patients who are considering ART procedures, embryologists, cell biologists and students in the field of reproduction.
Sean Ekins Predictive Approaches in Drug Discovery and Development. Biomarkers and In Vitro / In Vivo Correlations Sean Ekins Predictive Approaches in Drug Discovery and Development. Biomarkers and In Vitro / In Vivo Correlations Новинка

Sean Ekins Predictive Approaches in Drug Discovery and Development. Biomarkers and In Vitro / In Vivo Correlations

11896.9 руб.
Practical Utility of Biomarkers in Drug Discovery and Development covers all aspects of biomarker research applied to drug discovery and development and contains state-of-the-art appraisals on the practical utility of genomic, biochemical, and protein biomarkers. Case histories and lessons from successful and unsuccessful applications of biomarkers are included along with key chapters on GLP validation, safety biomarkers and proteomics biomarkers. Regulatory agency perspectives and initiatives both in the US and internationally are also discussed.
Valdir Cechinel-Filho Plant Bioactives and Drug Discovery. Principles, Practice, and Perspectives Valdir Cechinel-Filho Plant Bioactives and Drug Discovery. Principles, Practice, and Perspectives Новинка

Valdir Cechinel-Filho Plant Bioactives and Drug Discovery. Principles, Practice, and Perspectives

15448.74 руб.
An in-depth exploration of the applications of plant bioactive metabolites in drug research and development Highlighting the complexity and applications of plant bioactive metabolites in organic and medicinal chemistry, Plant Bioactives and Drug Discovery: Principles, Practice, and Perspectives provides an in-depth overview of the ways in which plants can inform drug research and development. An edited volume featuring multidisciplinary international contributions from acclaimed scientists researching bioactive natural products, the book provides an incisive overview of one of the most important topics in pharmaceutical studies today. With coverage of strategic methods of natural compound isolation, structural manipulation, natural products in clinical trials, quality control, and more, and featuring case studies on medicinal plants, the book serves as a definitive guide to the field of plant biodiversity as it relates to medicine. In addition, chapters on using natural products as drugs that target specific disease areas, including neurological disorders, inflammation, infectious diseases, and cancer, illustrate the myriad possibilities for therapeutic applications. Wide ranging and comprehensive, Plant Bioactives and Drug Discovery also includes important information on marketing, regulations, intellectual property rights, and academic-industry collaboration as they relate to plant-based drug research, making it an essential resource for advanced students and academic and industry professionals working in biochemical, pharmaceutical, and related fields.
Hugo Kubinyi Chemokine Receptors as Drug Targets Hugo Kubinyi Chemokine Receptors as Drug Targets Новинка

Hugo Kubinyi Chemokine Receptors as Drug Targets

16417.87 руб.
Chemokines are hormone-like signaling molecules secreted by cells to signal infection and guide the immune response. Following a decade of basic chemokine research, the pharmaceutical industry has now begun to exploit this crucial signaling pathway for the development of innovative drugs against AIDS, cancer, neural and autoimmune diseases. Here is the first reference focusing on these novel drug development opportunities. Opening with a general introduction on chemokine function and chemokine receptor biology, the second part covers the known implications of these signaling molecules in human diseases, such as cancer, neural disorders, and viral infection, including AIDS. The third part systematically surveys current drug development efforts at targeting individual chemokine receptors, as well as other chemokine interaction partners, including up-to-date reports from the pharmaceutical industry.
William Brock J. Nonclinical Safety Assessment. A Guide to International Pharmaceutical Regulations William Brock J. Nonclinical Safety Assessment. A Guide to International Pharmaceutical Regulations Новинка

William Brock J. Nonclinical Safety Assessment. A Guide to International Pharmaceutical Regulations

15862.53 руб.
Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Benson Heather A.E. Topical and Transdermal Drug Delivery. Principles and Practice Benson Heather A.E. Topical and Transdermal Drug Delivery. Principles and Practice Новинка

Benson Heather A.E. Topical and Transdermal Drug Delivery. Principles and Practice

11606.57 руб.
Practical drug development approaches presented by leading experts Designed to support the development of new, effective therapeutics, Topical and Transdermal Drug Delivery: Principles and Practice explains the principles underlying the field and then demonstrates how these principles are put into practice in the design and development of new drug products. Drawing together and reviewing the latest research findings, the book focuses on practical, tested, and proven approaches that are backed by industry case studies and the authors' firsthand experience. Moreover, the book emphasizes the mechanistic information that is essential for successful drug product development. Topical and Transdermal Drug Delivery: Principles and Practice is divided into two parts: Part One, Current Science, Skin Permeation, and Enhancement Approaches, offers readers a fundamental understanding of the underlying science in the field. It describes the principles and techniques needed to successfully perform experimental approaches, covering such issues as skin permeation, enhancement, and assessment. Part Two, Topical and Transdermal Product Development, guides readers through the complete product development process from concept to approval, offering practical tips and cautions from experts in the field. This part also discusses regulations that are specific to the development of dermal drug products. The final chapter explores current and future trends, forecasting new development techniques and therapeutics. Throughout the book, the authors clearly set forth the basic science and experimental procedures, making it possible for researchers to design their own experimental approaches and accurately interpret their results. With contributions from experienced drug researchers, this text is highly recommended for all researchers involved in topical and transdermal product development who need to know both the state of the science and the standards of practice.
Jameel Feroz Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Jameel Feroz Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Новинка

Jameel Feroz Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

17926.14 руб.
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Shayne Gad Cox Development of Therapeutic Agents Handbook Shayne Gad Cox Development of Therapeutic Agents Handbook Новинка

Shayne Gad Cox Development of Therapeutic Agents Handbook

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A comprehensive look at current drug discovery and development methods—and the roadmap for the future Providing both understanding and guidance in characterizing potential drugs and their production and synthesis, Development of Therapeutic Agents Handbook gives professionals a basic tool to facilitate research and development within this challenging process. This comprehensive text brings together, in one resource, a compendium of concepts, approaches, methodologies, and limitations that need to be considered in the formulation of therapeutic agents across a range of therapeutic fields. Both a reference and a call to action for the pharmaceutical industry, Development of Therapeutic Agents Handbook examines recent innovations taking shape in the various medical disciplines involved in drug discovery, and shows why these advances need to be embraced universally among researchers to improve their solution strategies. Additional subject matter includes: Extensive coverage and in-depth look into novel treatments and therapeutics Discussion of hot topics like new drugs and nutraceuticals, the discovery and development of vaccines, cancer therapeutics, and market overviews Coverage of therapeutic drug development for specific disease areas, such as cardiology, oncology, breast cancer, and kidney diseases As research in biology, chemistry, medicine, and technology rapidly progresses, it is becoming increasingly important for medical researchers to maintain an up-to-date knowledge base of emerging trends directing promising new therapies. Development of Therapeutic Agents Handbook serves this purpose, acting as both a one-stop reference rich in valid science, and a tool to carve out new pathways in the pursuit of bringing safer and more effective drugs to the marketplace.
Walter Korfmacher A. Mass Spectrometry for Drug Discovery and Drug Development Walter Korfmacher A. Mass Spectrometry for Drug Discovery and Drug Development Новинка

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Facilitates the discovery and development of new, effective therapeutics With coverage of the latest mass spectrometry technology, this book explains how mass spectrometry can be used to enhance almost all phases of drug discovery and drug development, including new and emerging applications. The book's fifteen chapters have been written by leading pharmaceutical and analytical scientists. Their contributions are based on a thorough review of the current literature as well as their own experience developing new mass spectrometry techniques to improve the ability to discover and develop new and effective therapeutics. Mass Spectrometry for Drug Discovery and Drug Development begins with an overview of the types of mass spectrometers that facilitate drug discovery and development. Next it covers: HPLC–high-resolution mass spectrometry for quantitative assays Mass spectrometry for siRNA Quantitative analysis of peptides Mass spectrometry analysis of biological drugs Applications that support medicinal chemistry investigations Mass spectrometry imaging and profiling Throughout the book, detailed examples underscore the growing role of mass spectrometry throughout the drug discovery and development process. In addition, images of mass spectra are provided to explain how results are interpreted. Extensive references at the end of each chapter guide readers to the primary literature in the field. Mass Spectrometry for Drug Discovery and Drug Development is recommended for readers in pharmaceutics, including medicinal chemists, analytical chemists, and drug metabolism scientists. All readers will discover how mass spectrometry can streamline and advance new drug discovery and development efforts.
Dianne Murphy Pediatric Drug Development Dianne Murphy Pediatric Drug Development Новинка

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Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
Robin Whelpton Introduction to Drug Disposition and Pharmacokinetics Robin Whelpton Introduction to Drug Disposition and Pharmacokinetics Новинка

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The application of knowledge of drug disposition, and skills in pharmacokinetics, are crucial to the development of new drugs and to a better understanding of how to achieve maximum benefit from existing ones. The book takes the reader from basic concepts to a point where those who wish to will be able to perform pharmacokinetic calculations and be ready to read more advanced texts and research papers. The book will be of benefit to students of medicine, pharmacy, pharmacology, biomedical sciences and veterinary science, including those who have elected to study the topic in more detail, such as via electives and special study modules. It will be of benefit to those involved in drug discovery and development, pharmaceutical and medicinal chemists, as well as budding toxicologists and forensic scientists who require the appropriate knowledge to interpret their findings and as an introductory text for clinical pharmacologists. Early chapters describe the basic principles of the topic while the later ones illustrate the application of those principles to modern approaches to drug development and clinical use. Full colour illustrations facilitate the learning experience and supporting material for course leaders and students can be found on the Companion Web Site
Ekins Sean Pharmaceutical Data Mining. Approaches and Applications for Drug Discovery Ekins Sean Pharmaceutical Data Mining. Approaches and Applications for Drug Discovery Новинка

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Leading experts illustrate how sophisticated computational data mining techniques can impact contemporary drug discovery and development In the era of post-genomic drug development, extracting and applying knowledge from chemical, biological, and clinical data is one of the greatest challenges facing the pharmaceutical industry. Pharmaceutical Data Mining brings together contributions from leading academic and industrial scientists, who address both the implementation of new data mining technologies and application issues in the industry. This accessible, comprehensive collection discusses important theoretical and practical aspects of pharmaceutical data mining, focusing on diverse approaches for drug discovery—including chemogenomics, toxicogenomics, and individual drug response prediction. The five main sections of this volume cover: A general overview of the discipline, from its foundations to contemporary industrial applications Chemoinformatics-based applications Bioinformatics-based applications Data mining methods in clinical development Data mining algorithms, technologies, and software tools, with emphasis on advanced algorithms and software that are currently used in the industry or represent promising approaches In one concentrated reference, Pharmaceutical Data Mining reveals the role and possibilities of these sophisticated techniques in contemporary drug discovery and development. It is ideal for graduate-level courses covering pharmaceutical science, computational chemistry, and bioinformatics. In addition, it provides insight to pharmaceutical scientists, principal investigators, principal scientists, research directors, and all scientists working in the field of drug discovery and development and associated industries.

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The first and only comprehensive review of current early childhood development theory, practices, policies, and the science behind them This unique and important bookprovides a comprehensive overview of the current theory, practices, and policies in early childhood development withinthe contexts of family, school, and community, and society at large. Moreover, it synthesizes scientifically rigorous research from an array of disciplines in an effort to identify the most effective strategies for promoting early childhood development. Research into childhood development is booming, and the scientific knowledge base concerning early childhood development is now greater than that of any other stage of the human life span. At the same time, efforts to apply that knowledge to early childhood practices, programs, and policies have never been greater or more urgent. Yet, surprisingly, until The Handbook of Early Childhood Development Programs, Practices, and Policies, there was no comprehensive, critical review of the applied science in the field. The book begins with in-depth coverage of child and family approaches. From there it moves onto a consideration of school- and community-based strategies. It concludes with a discussion of current social policies on health and development in early childhood and their implications. Provides a comprehensive overview of the state of the knowledge base, along with guidance for the future of the field Examines the underlying theory and basic science guiding efforts to promote early childhood development Critically reviews the strength of the empirical support for individual practices, programs, and policies Explores key opportunities and barriers policymakers and practitioners face when implementing various approaches Pays particular attention to socioeconomically disadvantaged and other disenfranchised populations The Handbook of Early Childhood Development Programs, Practices, and Policies is a valuable resource for practitioners, scholars, graduate students, and advanced undergraduate students across the social sciences who are interested in strengthening their understanding of current strategies for promoting early childhood development and the science informing those strategies.
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