Drug safety evaluation [[electronic resource] /] / Shayne Cox Gad
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| Autore: |
Gad Shayne C. <1948->
|
| Titolo: |
Drug safety evaluation [[electronic resource] /] / Shayne Cox Gad
|
| Pubblicazione: | Hoboken, NJ, : Wiley, c2009 |
| Edizione: | 2nd ed. |
| Descrizione fisica: | 1 online resource (1196 p.) |
| Disciplina: | 615.19 |
| 615/.19 | |
| Soggetto topico: | Drugs - Toxicology |
| Drugs - Testing | |
| Note generali: | Description based upon print version of record. |
| Nota di bibliografia: | Includes bibliographical references and index. |
| Nota di contenuto: | Drug Safety Evaluation; Contents; Preface; Acknowledgment; About the Author; 1. Drug Development Process and Global Pharmaceutical Marketplace; 2. Regulation of Human Pharmaceutical Safety; 3. Prior Art and Its Use in Safety Assessment Process; 4. Screens in Safety and Hazard Assessment; 5. Formulations, Routes, and Dosage Design; 6. Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in 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 Studies13. 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 Preclinical Evaluation of Biotechnology Products; 18. Safety Assessment of Inhalant and Dermal Route Drugs; 19. Special-Case Products: Imaging Agents and Oncology Drugs; 20. Occupational Toxicology in Pharmaceutical Industry | |
| 21. Strategy and Phasing for Nonclinical Drug Safety Evaluation in Discovery and Development of Pharmaceuticals22. Application of In Vitro Techniques in Drug Safety Assessment; 23. Evaluation of Human Tolerance and Safety in Clinical Trials: FIM Trials and Beyond; 24. Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses; 25. Statistics in Pharmaceutical Safety Assessment; 26. Combination Products: Drugs and Devices; 27. Qualification of Impurities, Degradants, Residual Solvents, and Leachables in Pharmaceuticals | |
| Appendix A. Selected Regulatory and Toxicological AcronymsAppendix 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 | |
| Sommario/riassunto: | Drug Safety Evaluation Second EditionShayne Cox Gad The updated and expanded safety guide to all aspects of the drug development process Drug Safety Evaluation, Second Edition 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. This Second Edition has been extensively revised and expanded to respond to the many changes |
| Titolo autorizzato: | Drug Safety Evaluation |
| ISBN: | 1-282-36841-9 |
| 9786612368417 | |
| 0-470-46415-1 | |
| 0-470-46409-7 | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910140133003321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |
Serie:
Pharmaceutical Development Series