Drug Safety Evaluation

Shayne Cox Gad , Dexter W. Sullivan, Jr. 지음

Wiley 2022년 12월 20일 출간

작품소개

책소개

Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing<

목차

PREFACE xxv ABOUT THE AUTHOR xxvii Chapter 1: The Drug Development Process and the Global Pharmaceutical Marketplace 1.1 Introduction 1.2 The Marketplace 1.3 History of Modern Therapeutics 1.4 The Drug Development Process 1.5 Strategies for Development: Large vs. Small Company or the Short vs. Long Game 1.5.1 Do Only What You Must (the short game) 1.5.2 Minimize the Risk of Subsequent Failure 1.6 Safety Assessment and the Evolution of Drug Safety 1.7 The Three Stages of Drug Safety Evaluation in the General Case Chapter 2: Regulation of Human Pharmaceutical Safety: Routes to Human Use and Market 2.1 Introduction 2.2 Brief History of US Pharmaceutical Law 2.2.1 1906: Pure Food and Drug Act 2.2.2 1938: Food, Drug, and Cosmetic Act 2.2.3 1962: Major Amendment 2.2.4 1992, 1997, 2002, 2007, 2012 and 2017: PDUFA, FDAMA, and FDARA 2.2.5 PREA: the Pediatric Research Equity Act 2.2.6 ICH: the International Conference on Harmonization 2.2.7 Electronic Recordings: Electronic Submission Impact 2.2.8 COVID-19 2.3 FDAMA Summary: Consequences and Other Regulations 2.4 Overview of US Regulations 2.4.1 Regulations: General Considerations 2.4.2 Regulations: Human Pharmaceuticals 2.4.3 Regulations: Environmental Impact 2.4.4 Regulations: Antibiotics 2.4.5 Regulations: Biologics 2.4.6 Regulations vs. Law

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작가정보

저자(글) Shayne Cox Gad

저자(글) Dexter W. Sullivan, Jr.