描述
Drug Safety Evaluation, 3rd Edition
Shayne Cox Gad
ISBN: 978-1-119-09739-6
920 pages
October 2016
Description
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
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Table of Contents
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
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