Drug Safety Evaluation
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Beschreibung
Drug Safety Evaluation
Second Edition
Shayne Cox Gad
The updated and expanded safety guide to all aspects of the drugdevelopment process
Drug Safety Evaluation, Second Edition presents anall-inclusive, practical guide for those who are responsible forensuring the safety of drugs and biologics for patients, for healthcare providers, for those involved in the manufacture of medicinalproducts, and for all those who need to understand how the safetyof these products is evaluated.
This Second Edition has been extensively revised and expanded torespond to the many changes in regulatory requirements as well aspharmaceutical and technological developments. Drawing upon morethan twenty years of experience, author Shayne Gad explains thescientific and philosophical bases for evaluating specific concerns(e.g., cardiovascular safety, immunogenicity, carcinogenicity,development toxicity, etc.) to provide both understanding andguidance for approaching new problems.
Individual chapters address not only the general cases forsafety evaluation of small and large molecules, but also all thesignificant major sub-cases: imaging agents, dermal and inhalationroute drugs, vaccines, and gene-therapy products. Among the widevariety of topics covered are:
* 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 clinicaltrials
More pertinent and practical than ever to the industry, DrugSafety Evaluation, Second Edition provides a road map for safetyassessment as an integral part of the development of new drugs andtherapeutics.
Autor*in
Shayne Cox Gad
Themen in »Drug Safety Evaluation«
Chemie Chemistry Drug Discovery & Development Medical Science Medizin Pharmacology & Pharmaceutical Medicine Pharmakologie u. Pharmazeutische Medizin Toxicology Toxikologie Wirkstoffforschung u. -entwicklung
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"The author is to be admired for taking a very difficult topic andchallenging task and making it more accessible and more timely thanit was before." (Current Engineering Practice, 2010)
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