Description
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. 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. Key features include: – Sources of information for consideration in study and program design and in safety evaluation; – the drug development process and the global pharmaceutical marketplace and regulation of pharmaceutical safety; – genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing. 963 p.
- Shayne Cox Gad. PhD, DABT; He has more than 47 years of experience as a toxicologist; Statistical consultant; Manager; and Consultant on Research and Development; He is the Principal of Gad Consulting Services, Raleigh, NC (USA).
- Dexter W. Sullivan, Jr. MS, DABT; Senior toxicologist, Gad Consulting Services, Raleigh, NC (USA).
- Publication date (digital version): 2023-01.
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