Drug safety evaluation
Author(s)
Bibliographic Information
Drug safety evaluation
J. Wiley, c2002
- : cloth
Available at 9 libraries
  Aomori
  Iwate
  Miyagi
  Akita
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  Tochigi
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  Niigata
  Toyama
  Ishikawa
  Fukui
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  Nagano
  Gifu
  Shizuoka
  Aichi
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  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
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  United Kingdom
  Germany
  Switzerland
  France
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  United States of America
Note
Includes bibliographical references and index
Description and Table of Contents
Description
"Drug Safety Evaluation" presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, "Drug Safety Evaluation" covers a wide variety of topics, including: acute toxicity testing in pharmaceutical safety evaluation; genotoxicity; safety assessment of inhalant drugs; immunotoxicology in pharmaceutical development; large animal studies; and, evaluation of human tolerance and safety in clinical trials.
"Drug Safety Evaluation" provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Table of Contents
Preface. About the Author. Strategy and Phasing for Drug Safety Evaluation in the Discovery and Development of Pharmaceuticals. Regulation of Human Pharmaceutical Safety. Information Sources: Building and Maintaining Data Files. Screens in Safety and Hazard Assessments. Acute Toxicity Testing in Drug Safety Evaluation. Genotoxicity. Subchronic and Chronic Toxicity Studies. Developmental and Reproductive Toxicity Testing. Carcinogenicity Studies. Safety Assessment of Inhalant Drugs. Irritation and Local Tissue Tolerance in Pharmaceutical Safety Assessment. Special Concerns for the Preclinical Evaluation of Biotechnology Products. Formulations, Routes, and Dosage Designs. Occupational Toxicology in the Pharmaceutical Industry. Immunotoxicology in Pharmaceutical Development. Large Animal Studies. The Application of In Vitro Techniques in Drug Safety Assessment. Pharmacokinetics/Toxicokinetics in Drug Safety Evaluation. Safety Pharmacology. Evaluation of Human Tolerance and Safety in Clinical Trials: Phase I and Beyond. Postmarketing Safety Evaluation: Monitoring Assessing and Reporting of Adverse Drug Response (ADRs). Statistics in Pharmaceutical Safety Assessment. Appendix A: Selected Relatory and Toxicological Acronyms. Appendix B: Definition of Terms and Lexicon of Clinical Observations in Nonclinical (Animal) Studies. Appendix C: Notable Regulatory Internet Addresses. Appendix D: Glossary of Terms used in Clinical Evaluation of Therapeutic Agents. Index.
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