Drug Safety Evaluation

Drug Safety Evaluation

Author(s): Shayne C. Gad

Published Online: 26 AUG 2003

Print ISBN: 9780471407270

Online ISBN: 9780471462996

DOI: 10.1002/0471462993

About this Book

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

Table of contents

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