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Drug Safety Evaluation, 2nd Edition

ISBN: 978-0-470-46409-0
1056 pages
June 2009
Drug Safety Evaluation, 2nd Edition (0470464097) cover image


Drug Safety Evaluation

Second Edition

Shayne Cox Gad

The updated and expanded safety guide to all aspects of the drug development process

Drug Safety Evaluation, Second Edition 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.

This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory requirements as well as pharmaceutical and technological developments. Drawing upon more than twenty years of experience, author Shayne Gad explains the scientific and philosophical bases for evaluating specific concerns (e.g., cardiovascular safety, immunogenicity, carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems.

Individual chapters address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products. Among the wide variety of topics covered are:

  • 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

More pertinent and practical than ever to the industry, Drug Safety Evaluation, Second Edition provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.

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Table of Contents


About the Author.

Chapter 1: The Drug Development Process and the Global Pharmaceutical Marketplace.

Chapter 2: Regulation of Human Pharmaceutical Safety.

Chapter 3: Prior Art and its Use in the Safety Assessment Process.

Chapter 4: Screens in Safety and Hazard Assessment.

Chapter 5: Formulations, Routes, and Dosage Regimens.

Chapter 6: Acute Toxicity Testing Drug Safety Evaluation.

Chapter 7: Genotoxicity.

Chapter 8: Repeat Dose Toxicity Studies.

Chapter 9: Immunotoxicology in Drug Development.

Chapter 10: Nonrodent Animal Studies.

Chapter 11: Developmental and Reproductive Toxicity Testing.

Chapter 12: Carcinogenicity Studies.

Chapter 13: Histopathology in Nonclinical Pharmaceutical Safety Assessment.

Chapter 14: Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment.

Chapter 15: Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation.

Chapter 16: Safety Pharmacology.

Chapter 17: Special Concerns for the Preclinical Evaluation of Biotechnology Products.

Chapter 18: Safety Assessment of Inhalant Drugs and Dermal Route Drugs.

Chapter 19: Special Case Products: Excipients, Blood Products, and Imaging Agents.

Chapter 20: Occupational Toxicology in the Pharmaceutical Industry.

Chapter 21: Strategy and Phasing for Non Clinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals.

Chapter 22: The Application of In Vitro Techniques in Drug Safety Assessment.

Chapter 23: Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond.

Chapter 24: Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs).

Chapter 25: Statistics in Pharmaceutical Safety Assessment.

Chapter 26: Combination Products: Drugs and Devices.

Chapter 27: Impurities and Degradants.

Appendix A: Selected Regulatory and Toxicological Acronyms.

Appendix B: Definition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies.

Appendix C: Notable Regulatory Internet Address.

Appendix D: Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents.

Appendix E: Common Vehicles and Nonclinical Formulation Components.

Appendix F: Global Directory of Contract Toxicology Labs.

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Author Information

Shayne Cox Gad, PHD, DABT, ATS, is the Principal of Gad Consulting Services. He has more than thirty years of experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of thirty-nine books and numerous papers, presentations, and other publications.

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"The author is to be admired for taking a very difficult topic and challenging task and making it more accessible and more timely than it was before." (Current Engineering Practice, 2010)

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