Drug Safety Evaluation

24.04.2002

Englisch

9780471407270

John Wiley & Sons

Nein

Shayne Cox Gad

1024

1

Gebundene Ausgabe

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.

Pharmakologie, Arzneimittel, Arzneimittelnebenwirkung

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.

240 mm

16 cm