Drug Safety Evaluation

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John Wiley & Sons, Sep 5, 2003 - Medical - 1024 pages
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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Contents

About the Author
x
Chapter 1 Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals
1
Chapter 2 Regulation of Human Pharmaceutical Safety
30
Chapter 3 Information Sources Building and Maintaining Data Files
99
Chapter 4 Screens in Safety and Hazard Assessment
112
Chapter 5 Acute Toxicity Testing in Drug Safety Evaluation
130
Chapter 6 Genotoxicity
176
Chapter 7 Subchronic and Chronic Toxicity Studies
237
Chapter 15 Immunotoxicology in Pharmaceutical Development
527
Chapter 16 Nonrodent Animal Studies
595
Chapter 17 The Applicatioin of In Vitro Techniques in Drug Safety Assessment
634
Chapter 18 Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation
691
Chapter 19 Safety Pharmacology
737
Chapter 20 Evaluation of Human Tolerance and Safety in Clinical Trials Phase I and Beyond
764
Chapter 21 Postmarketing Safety Evaluation Monitoring Assessing and Reporting of Adverse Drug Responses ADRs
831
Chapter 22 Statistics in Pharmaceutical Safety Assessment
862

Chapter 8 Developmental and Reproductive Toxicity Testing
258
Chapter 9 Carcinogenicity Studies
297
Chapter 10 Safety Assessment of Inhalant Drugs
335
Chapter 11 Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment
367
Chapter 12 Special Concerns for the Preclinical Evaluation of Biotechnology Products
404
Chapter 13 Formulations Routes and Dosage Designs
442
Chapter 14 Occupational Toxicology in the Pharmaceutical Industry
505
Appendix A Selected Regulatory and Toxicological Acronyms
971
Appendix B Definition of Terms and Lexicon of Clinical Observations in Nonclinical Animal Studies
975
Appendix C Notable Regulatory Internet Addresses
979
Appendix D Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents
990
Index
997
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About the author (2003)

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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