Drug Safety Evaluation
Drug Safety Evaluation
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DOI：
10.1002/0471462993
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发表时间：
2002-04
期刊：
影响因子：
--
通讯作者：
S. Gad
中科院分区：
文献类型：
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作者：
S. Gad
序言。关于作者。第1章药物开发过程和全球制药市场。第二章：人体用药安全法规。第3章：现有技术及其在安全评估过程中的使用。第4章安全与危害评估中的屏幕。第5章：配方，途径和剂量方案。第六章：急性毒性试验药物安全性评价。第七章：基因毒性第8章：重复给药毒性研究。第9章药物开发中的免疫毒理学第10章：非啮齿类动物研究第11章：发育和生殖毒性试验。第12章：致癌性研究。第13章：非临床药物安全性评估中的组织学。第14章：药物安全性评估中的刺激性和局部组织耐受性。第15章：药物安全性评价中的药代动力学和毒理学。第16章：安全药理学第17章：生物技术产品临床前评价的特殊问题。第18章：吸入性药物和经皮给药的安全性评估。第19章特殊情况产品：辅料、血液制品和显像剂。第20章制药行业的职业毒理学第21章：药物发现和开发中非临床药物安全性评价的策略和阶段划分。第22章体外技术在药物安全性评价中的应用第23章临床试验中人体耐受性和安全性的评价：I期及以后第24章：上市后安全性评价：药物不良反应（ADR）的监测、评估和报告。第25章：药物安全性评价中的统计学。第26章组合产品：药品和器械第27章：杂质和降解物附录A：选定的监管和毒理学缩略语。附录B：非临床（动物）研究中临床观察结果的术语和词汇定义。附录C：值得注意的监管互联网地址。附录D：治疗药物临床评价中使用的术语表。附录E：常用溶媒和非临床制剂组分。附录F：全球合同毒理学实验室目录。
Preface. About the Author. Chapter 1: The Drug Development Process and the Global Pharmaceutical Marketplace. Chapter 2: Regulation of Human Pharmaceutical Safety. Chapter 3: Prior Art and its Use in the Safety Assessment Process. Chapter 4: Screens in Safety and Hazard Assessment. Chapter 5: Formulations, Routes, and Dosage Regimens. Chapter 6: Acute Toxicity Testing Drug Safety Evaluation. Chapter 7: Genotoxicity. Chapter 8: Repeat Dose Toxicity Studies. Chapter 9: Immunotoxicology in Drug Development. Chapter 10: Nonrodent Animal Studies. Chapter 11: Developmental and Reproductive Toxicity Testing. Chapter 12: Carcinogenicity Studies. Chapter 13: Histopathology in Nonclinical Pharmaceutical Safety Assessment. Chapter 14: Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment. Chapter 15: Pharmacokinetics and Toxicokinetics in Drug Safety Evaluation. Chapter 16: Safety Pharmacology. Chapter 17: Special Concerns for the Preclinical Evaluation of Biotechnology Products. Chapter 18: Safety Assessment of Inhalant Drugs and Dermal Route Drugs. Chapter 19: Special Case Products: Excipients, Blood Products, and Imaging Agents. Chapter 20: Occupational Toxicology in the Pharmaceutical Industry. Chapter 21: Strategy and Phasing for Non Clinical Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals. Chapter 22: The Application of In Vitro Techniques in Drug Safety Assessment. Chapter 23: Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond. Chapter 24: Postmarketing Safety Evaluation: Monitoring, Assessing, and Reporting of Adverse Drug Responses (ADRs). Chapter 25: Statistics in Pharmaceutical Safety Assessment. Chapter 26: Combination Products: Drugs and Devices. Chapter 27: Impurities and Degradants. 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 and Nonclinical Formulation Components. Appendix F: Global Directory of Contract Toxicology Labs.