Drug safety evaluation
"Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--
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| Format: | Book |
| Language: | English |
| Published: |
Hoboken, New Jersey :
Wiley
c2017
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| Edition: | 3rd ed |
| Subjects: |
Table of Contents:
- 1. The Drug Development Process And The Global Pharmaceutical Marketplace
- 2. Regulation Of Human Pharmaceutical Safety
- 3. Data Mining
- 4. Screens In Safety And Hazard Assessment
- 5. Formulations, Routes, And Dosage Regimens
- 6. Nonclinical Manifestations, Mechanisms, And End Points Of Drug Toxicity
- 7. Pilot Toxicity Testing In Drug Safety Evaluation
- 8. Repeat-Dose Toxicity Studies
- 9. Genotoxicity
- 10. Qsar Tools For Drug Safety
- 11. Immunotoxicology In Drug Development
- 12. Nonrodent Animal Studies
- 13. Developmental And Reproductive Toxicity Testing
- 14. Carcinogenicity Studies
- 15. Histopathology In Nonclinical Pharmaceutical Safety Assessment
- 16. Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment
- 17. Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation
- 18. Safety Pharmacology
- 19. Special Concerns For The Preclinical Evaluation Of Biotechnology Products
- Safety Assessment Of Inhalant Drugs And Dermal Route Drugs
- 20. Special Case Products
- 21. Special Case Products
- 22. Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile Toxicology)
- 23. Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology
- 24. Occupational Toxicology In The Pharmaceutical Industry
- 25. Strategy And Phasing For Nonclinical Drug Safety Evaluation In The Discovery And Development Of Pharmaceuticals
- 26. The Application Of In Vitro Techniques In Drug Safety Assessment
- 27. Evaluation Of Human Tolerance And Safety In Clinical Trials
- 28. Postmarketing Safety Evaluation
- 29. Statistics In Pharmaceutical Safety Assessment
- 30. Combination Products
- 31. Qualification Of Impurities, Degradants, Residual Solvents, Metals, And Leachables In Pharmaceuticals
- 33. Tissue, Cell, And Gene Therapy