Drug Safety Evaluation

by Gad, Shayne Cox

• ISBN13: 9780470253168
• ISBN10: 0470253169
• Edition: 2nd
• Format: Hardcover
• Copyright: 2009-06-09
• Publisher: Wiley
• More Book Details

Summary

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

Author Biography

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.

Table of Contents

Preface	p. ix
Acknowledgment	p. x
About the Author	p. xi
Drug Development Process and Global Pharmaceutical Marketplace	p. 1
Regulation of Human Pharmaceutical Safety	p. 19
Prior Art and Its Use in Safety Assessment Process	p. 89
Screens in Safety and Hazard Assessment	p. 103
Formulations, Routes, and Dosage Design	p. 121
Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation	p. 185
Genotoxicity	p. 234
Repeat-Dose Toxicity Studies	p. 304
Immunotoxicology in Drug Development	p. 326
Nonrodent Animal Studies	p. 400
Developmental and Reproductive Toxicity Testing	p. 441
Carcinogenicity Studies	p. 481
Histopathology in Nonclinical Pharmaceutical Safety Assessment	p. 520
Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment	p. 531
Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation	p. 568
Safety Pharmacology	p. 619
Special Concerns for Preclinical Evaluation of Biotechnology Products	p. 644
Safety Assessment of Inhalant and Dermal Route Drugs	p. 688
Special-Case Products: Imaging Agents and Oncology Drugs	p. 725
Occupational Toxicology in Pharmaceutical Industry	p. 737
Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals	p. 759
Application of In Vitro Techniques in Drug Safety Assessment	p. 788
Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond	p. 861
Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses	p. 935
Statistics in Pharmaceutical Safety Assessment	p. 972
Combination Products: Drugs and Devices	p. 1083
Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals	p. 1100
Selected Regulatory and Toxicological Acronyms	p. 1117
Definition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies	p. 1121
Notable Regulatory Internet Addresses	p. 1125
Glossary of Terms Used in Clinical Evaluation of Therapeutic Agents	p. 1133
Common Vehicles for Nonclinical Evaluation of Therapeutic Agents	p. 1140
Global Directory of Contract Toxicology Laboratories	p. 1161
Index	p. 1171
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