Drug Safety Evaluation

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.

Preface. 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.