Drug Safety Evaluation
(Sprache: Englisch)
With the development of new drugs comes the need for new, up-to-date standards for safety assessment. This book presents a practical guide for all those responsible for ensuring the safety of drugs and biologics to patients and health care providers.
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With the development of new drugs comes the need for new, up-to-date standards for safety assessment. This book presents a practical guide for all those responsible for ensuring the safety of drugs and biologics to patients and health care providers.
Klappentext zu „Drug Safety Evaluation “
A comprehensive safety guide to all aspects of the drug development processDrug 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 Evaluation of human tolerance and safety in clinical trialsDrug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics.
Inhaltsverzeichnis zu „Drug Safety Evaluation “
PrefaceAbout 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
Autoren-Porträt von Shayne Cox Gad
SHAYNE C. GAD, PhD, has been the Principal of Gad Consulting Services since 1994. He has previously served as director of toxicology and pharmacology for Synergen, director of medical affairs technical support services for Becton Dickinson, and senior director of product safety and pharmacokinetics for G.D. Searle.
Bibliographische Angaben
- Autor: Shayne Cox Gad
- 2002, VIII, 1007 Seiten, Maße: 24 cm, Gebunden, Englisch
- Verlag: Wiley & Sons
- ISBN-10: 0471407275
- ISBN-13: 9780471407270
Sprache:
Englisch
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