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Drug Safety Evaluation, 3rd Edition
-獸醫科
- 編號: 0-0--------19097396
- 作者:Shayne Cox Gad
- 原價-12000    - (熱賣價)11200     - 節省 ↓7%
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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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