Title In vivo Models for Drug Discovery

Published Hoboken : Wiley, 2014

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Description 1 online resource (595 pages) Series Methods and Principles in Medicinal Chemistry Methods and principles in medicinal chemistry. Contents In Vivo Models for Drug Discovery; Contents; List of Contributors; Preface; A Personal Foreword; Part I: Transversal Issues Concerning Animal Models in Drug Discovery; 1 The 3Ns of Preclinical Animal Models in Biomedical Research; 1.1 First N: The Need for Use of Animal Models; 1.2 Second N: The Need for Better Animal Models; 1.2.1 Unbiased Design; 1.2.2 Comprehensive Reporting; 1.2.3 Selection of the Animal Model Based on Its Validity Attributes; 1.2.4 Appropriate Time and Dosing; 1.2.5 Use of Biomarkers; 1.2.6 Use of Various Animal Models 1.2.7 Quantitative, Multiple, and Cross-Predictive Measurements1.2.8 Pharmacokinetic-Pharmacodynamic Integration; 1.2.9 Predefinition and Adherence to the Desired Product Profile; 1.2.10 Comparison with Gold Standard References; 1.2.11 Reverse Translation/Backtranslation (Bedside-to-Bench Approach); 1.3 Third N: The Need for 3Rs Guiding Principles; References; 2 Alternative Models in Drug Discovery and Development Part I: In Silico and In Vitro Models; 2.1 Introduction; 2.2 In Silico Models; 2.2.1 Quantitative Structure-Activity Relationship; 2.2.2 Biokinetic Modeling 2.2.3 Disease- and Patient-Specific In Silico Models2.3 In Vitro Models; 2.3.1 Primary Cells, Cell Lines, Immortalized Cell Lines, and Stem Cells; 2.3.2 Advanced In Vitro Models for the Prediction of Drug Toxicity; 2.3.3 In Vitro Tumor Models; References; 3 Alternative Models in Drug Discovery and Development Part II: In Vivo Nonmammalian and Exploratory/Experimental Human Models; 3.1 Introduction; 3.2 In Vivo Nonmammalian Models; 3.2.1 Zebrafish; 3.2.2 D. melanogaster; 3.2.3 C. elegans; 3.3 In Vivo Exploratory and Experimental Human Models 3.3.1 Phase 0 (Exploratory Human Models): Microdosing Studies3.3.2 Phase IB/IIA (Proof-of-Concept) Studies: Experimental Human Models; References; 4 Ethical Issues and Regulations and Guidelines Concerning Animal Research; 4.1 Introduction; 4.2 Current Use of Animals in Biomedical and Pharmaceutical Research; 4.3 Ethical Concerns and Positions on Animal Research; 4.4 General Principles for the Ethical Use of Animals in Research; 4.4.1 The 3Rs Principles (Replacement, Reduction, and Refinement); 4.4.2 The Principle of Justification; 4.4.3 The Principle of Responsibility 4.5 Regulatory Framework for Use of Animals in Research4.5.1 European Union; 4.5.2 The United States; 4.5.3 Canada; 4.5.4 Japan; 4.5.5 Australia; 4.5.6 India; 4.5.7 China; 4.5.8 Brazil; 4.5.9 Countries without a Specific Legal Framework; Acknowledgment; References; 5 Regulatory Issues: Safety and Toxicology Assessment; 5.1 Introduction; 5.1.1 Animal Testing; 5.1.2 Regulatory Context; 5.1.3 Clinical Context; 5.2 Animal Species in Toxicology Studies; 5.2.1 Rodents; 5.2.2 Nonrodents; 5.2.3 Nonconventional Animal Models; 5.3 Toxicology Studies; 5.3.1 General Principles Summary This one-stop reference is the first to present the complete picture -- covering all relevant organisms, from single cells to mammals, as well as all major disease areas, including neurological disorders, cancer and infectious diseases. Addressing the needs of the pharmaceutical industry, this unique handbook adopts a broad perspective on the use of animals in the early part of the drug development process, including regulatory rules and limitations, as well as numerous examples from real-life drug development projects. After a general introduction to the topic, the expert contributors Notes 5.3.2 General and Repeated Dose Toxicity Studies Bibliography Includes bibliographical references and index Notes Print version record Subject Drug development. Animal models in research. Drugs. Pharmaceutical Preparations MEDICAL -- Pharmacology. Drugs Animal models in research Drug development Form Electronic book Author Maldonado, Rafael Hamon, Michel Mannhold, Raimund Kubinyi, Hugo Folkers, Gerd ISBN 9783527679379 3527679375 9783527333288 3527333282 9783527679362 3527679367 9783527679355 3527679359 9783527679348 3527679340 9781322024530 1322024537

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