This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition INDICE: Preface: ix .About the Author xi .Chapter 1: The Drug Development Process and the Global Pharmaceutical Marketplace .Chapter 2: Regulation of Human Pharmaceutical Safety: Routes to Human Use and Market .Chapter 3: Data Mining: Sources of Information for Consideration in Study and Program Design and in Safety Evaluation .Chapter 4: Screens in Safety and Hazard Assessment .Chapter 5: Formulations, Routes, and Dosage Regimens .Chapter 6: Nonclinical Manifestations, Mechanisms and Endpoints of Drug Toxicity .Chapter 7: Pilot Toxicity Testing in Drug Safety Evaluation: MTD and DRF .Chapter 8: Repeat Dose Toxicity Studies .Chapter 9: Genotoxicity .Chapter 10: QSAR Tools for Drug Safety .Chapter 11: Immunotoxicology in Drug Development .Chapter 12: Nonrodent Animal Studies .Chapter 13: Developmental and Reproductive Toxicity Testing .Chapter 14: Carcinogenicity Studies .Chapter 15: Histopathology in Nonclinical Pharmaceutical Safety Assessment .Chapter 16: Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment .Chapter 17: Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation .Chapter 18: Safety Pharmacology .Chapter 19: Special Concerns for the Preclinical Evaluation of Biotechnology Products .Chapter 20: Safety Assessment of Inhalant Drugs and Dermal Route Drugs .Chapter 21: Special Case Products: Imaging Agents .Chapter 22: Special Case Products: Drugs for the Treatment of Cancer .Chapter 23: Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile Toxicology) .Chapter 24: Imaging, Imaging Agents and Radiopharmaceuticals in Nonclinical Toxicology .Chapter 25: Occupational Toxicology in the Pharmaceutical Industry .Chapter 26: Strategy and Phasing for Non Clinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals .Chapter 27: The Application of In Vitro Techniques in Drug Safety Assessment .Chapter 28: Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond .Chapter 29: Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs) .Chapter 30: Statistics in Pharmaceutical Safety Assessment .Chapter 31: Combination Products: Drugs and Devices .Chapter 32: Qualification of Impurities, Degradants, Residual Solvents, Metals and Leachables in Pharmaceuticals .Chapter 33: Tissue, Cell and Gene Therapy .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 Address .Appendix D: Glossary of Terms Used in the Clinical Evaluation of Therapeutic Agents .Appendix E: Common Vehicles for the Non Clinical Evaluation of Therapeutic Agents .Appendix F: Global Directory of Contract Toxicology Labs
- ISBN: 978-1-119-09739-6
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 920
- Fecha Publicación: 01/12/2016
- Nº Volúmenes: 1
- Idioma: Inglés