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Drug Safety Evaluation
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ISBN
:
9780471462996
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Publisher
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John Wiley & Sons
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Subject
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Medical Study & Revision Guides & Reference Material
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Binding
:
Unknown
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Year
:
2003
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19193.0
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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 evaluationGenotoxicitySafety assessment of inhalant drugsImmunotoxicology in pharmaceutical developmentLarge animal studiesEvaluation 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.
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Author Biography
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.
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