Full Description
Government regulatory agencies must approve any drug before it can be sold. This new edition of Drug Safety Evaluation presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Addressing specific approaches to evaluating hazards, including problems and solutions, the book covers the scientific and philosophical bases for evaluation of specific concerns to provide both understanding and guidance for approaching new problems. This all-inclusive guide is of paramount interest to pharmaceutical scientists, toxicologists, drug safety scientists, academic researchers, and grad-level students.
Contents
Preface. About the Author. Chapter 1the 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.
