Drug safety evaluation
Author(s)
Bibliographic Information
Drug safety evaluation
Wiley, c2009
2nd ed
- : cloth
Available at 3 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Includes bibliographical references and index
Description and Table of Contents
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.
Table of Contents
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.
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