Book Description
This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional" toxicology in the risk assessment and risk management of pharmaceuticals.
Table of Contents
Chapter 1: Introduction
Chapter 2: The Regulatory Environment
Chapter 3: Toxicological development: Roles and Responsibilities
Chapter 4: Contract Research Organizations
Chapter 5: Safety Pharmacology
Chapter 6: Formulations, Impurities and Toxicokinetics
Chapter 7: General Toxicology
Chapter 8: Genetic Toxicology
Chapter 9: Developmental and reproductive toxicology
Chapter 10: Data analysis, report writing and regulatory documentation
Chapter 11: Risk Management
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