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Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition
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ISBN
:
9781439845677
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Publisher
:
CRC Press
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Subject
:
Medicine: General Issues
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Binding
:
HARDCOVER
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Pages
:
213
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Year
:
2012
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15960.0
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Description
This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and internationalx2014;especially Europe and Japan) and updated test methods, interpretation, and science.
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Author Biography
Shayne Cox Gad is Principal at Gad Consulting Services in Cary, North Carolina. He has over 33 years experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries.
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