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Evaluation of Human Tolerance and Safety in Clinical Studies: Phase I and Beyond by Gad, Shayne C. is a scholarly article available to read on EtoBox.

What is Evaluation of Human Tolerance and Safety in Clinical Studies: Phase I and Beyond about?

Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: Acute toxicity testing in pharmaceutical safety evaluation Genotoxicity Safety assessment of inhalant drugs Immunotoxicology in pharmaceutical development Large animal studies Evaluation of human tolerance and safety in clinical trials Drug Safety Evalua

Author

Gad, Shayne C.

Publisher

John Wiley & Sons, Incorporated

Published

2002

Language

EN

ISBN

9780471462996