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.

Drug Safety Evaluation has individual chapters that address not only the general cases for safety evaluation of small and large molecules, but also all the significant major sub-cases: imaging agents, dermal and inhalation route drugs, vaccines, and gene-therapy products.

Contents

1. The Drug Development Process and the Global Pharmaceutical Marketplace
2. Regulation of Human Pharmaceutical Safety
3. Prior Art and its Use in the Safety Assessment Process
4. Screens in Safety and Hazard Assessment
5. Formulations, Routes, and Dosage Regimens
6. Acute Toxicity Testing Drug Safety Evaluation
7. Genotoxicity
8. Repeat Dose Toxicity Studies
9. Immunotoxicology in Drug Development
10. Nonrodent Animal Studies
11. Developmental and Reproductive Toxicity Testing
12. Carcinogenicity Studies
13. Histopathology in Nonclinical Pharmaceutical Safety Assessment
14. Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment
15. Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation
16. Safety Pharmacology
17. Special Concerns for the Preclinical Evaluation of Biotechnology Products
18. Safety Assessment of Inhalant Drugs and Dermal Route Drugs
19. Special Case Products: Excipients, Blood Products, and Imaging Agents
20. Occupational Toxicology in the Pharmaceutical Industry
21. Strategy and Phasing for Non Clinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals
22. The Application of In Vitro Techniques in Drug Safety Assessment
23. Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond
24. Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs)
25. Statistics in Pharmaceutical Safety Assessment
26. Combination Products: Drugs and Devices

Index

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