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Drug Safety Evaluation

ISBN: 978-0-471-45929-3
1024 pages
September 2003
Drug Safety Evaluation (0471459291) cover image
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 Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
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Preface.

About the Author.

Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals.

Regulation of Human Pharmaceutical Safety.

Information Sources: Building and Maintaining Data Files.

Screens in Safety and Hazard Assessments.

Acute Toxicity Testing in Drug Safety Evaluation.

Genotoxicity.

Subchronic and Chronic Toxicity Studies.

Developmental and Reproductive Toxicity Testing.

Carcinogenicity Studies.

Safety Assessment of Inhalant Drugs.

Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment.

Special Concerns for the Preclinical Evaluation of Biotechnology Products.

Formulations, Routes, and Dosage Designs.

Occupational Toxicology in the Pharmaceutical Industry.

Immunotoxicology in Pharmaceutical Development.

Large Animal Studies.

The Application of In Vitro Techniques in Drug Safety Assessment.

Pharmacokinetics/Toxicokinetics in Drug Safety Evaluation.

Safety Pharmacology.

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

Postmarketing Safety Evaluation: Monitoring Assessing and Reporting of Adverse Drug Response (ADRs).

Statistics in Pharmaceutical Safety Assessment.

Appendix A: Selected Relatory and Toxicological Acronyms.

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

Appendix C: Notable Regulatory Internet Addresses.

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

Index.
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SHAYNE C. GAD, PhD, has been the Principal of Gad Consulting Services since 1994. He has previously served as director of toxicology and pharmacology for Synergen, director of medical affairs technical support services for Becton Dickinson, and senior director of product safety and pharmacokinetics for G.D. Searle.
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"For toxicologic pathologists, this book is the most useful as a reference book in a departmental library." (Veterinary Pathology, November 2004)

"Gad brings…25 years of experience...to this practical guide..." (SciTech Book News, Vol. 26, No. 2, June 2002)

"...offers an accumulation of facts and knowledge of a highly specialized and intense industry from an individual who has been successful in innovations and quality assurance...." (Veterinary and Human Toxicology, Vol. 45, No. 1, February 2003)

"...it is a substantial book and accordingly should be considered a definitive reference work in this branch of toxicology." (Journal of Applied Toxicology, March-April 2003)

"...a definitive guide for those in the pharmaceutical industry who need to know how their products are evaluated and approved." (Business Horizons, January-February 2003)

"This book provides excellent treatise on drug safety evaluation...an excellent guide and reference..." (Pharmaceutical Research, Vol. 20, No. 6, June 2003)

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