Drug safety evaluation /

Drug safety evaluation /

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Bibliographic Details
Main Author: Gad, Shayne C., 1948-
Format: eBook
Language:English
Published: Hoboken, N.J. : Wiley, [2009]
Edition:2nd ed.
Series:Wiley online library.
Subjects:
Arzneimittelsicherheit.
Drug Evaluation, Preclinical.
Drug Evaluation.
Product Surveillance, Postmarketing.
Drugs > Testing.
Drugs > Toxicology.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Front Matter
  • Drug Development Process and Global Pharmaceutical Marketplace
  • Regulation of Human Pharmaceutical Safety
  • Prior Art and Its Use in Safety Assessment Process
  • Screens in Safety and Hazard Assessment
  • Formulations, Routes, and Dosage Design
  • Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation
  • Genotoxicity
  • Repeat-Dose Toxicity Studies
  • Immunotoxicology in Drug Development
  • Nonrodent Animal Studies
  • Developmental and Reproductive Toxicity Testing
  • Carcinogenicity Studies
  • Histopathology in Nonclinical Pharmaceutical Safety Assessment
  • Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment
  • Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation
  • Safety Pharmacology
  • Special Concerns for Preclinical Evaluation of Biotechnology Products
  • Safety Assessment of Inhalant and Dermal Route Drugs
  • Special-Case Products: Imaging Agents and Oncology Drugs
  • Occupational Toxicology in Pharmaceutical Industry
  • Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals
  • Application of In Vitro Techniques in Drug Safety Assessment
  • Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond
  • Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses
  • Statistics in Pharmaceutical Safety Assessment
  • Combination Products: Drugs and Devices
  • Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals
  • 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 Addresses
  • Appendix D: Glossary of Terms Used in Clinical Evaluation of Therapeutic Agents
  • Appendix E: Common Vehicles for Nonclinical Evaluation of Therapeutic Agents
  • Appendix F: Global Directory of Contract Toxicology Laboratories
  • Index.