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" Safety pharmacology in pharmaceutical development : "
Shayne C. Gad
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BL
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| Record Number
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643197
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dltt
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| Main Entry
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Gad, Shayne C.,1948-
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| Title & Author
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Safety pharmacology in pharmaceutical development : : approval and post marketing surveillance /\ Shayne C. Gad
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| Edition Statement
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2nd ed
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| Publication Statement
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Boca Raton, FL :: CRC Press,, c2012
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| Page. NO
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xv, 197 p. :: ill. ;; 24 cm
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| ISBN
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9781439845677 (hardback : alk. paper)
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: 1439845670 (hardback : alk. paper)
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: 9781439845684 (ebook)
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: 1439845689 (ebook)
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| Notes
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Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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Safety pharmacology: background, history, issues and concerns -- Regulatory requirements: ICH, FDA, EMA, and Japan -- Principles of screening and study design -- Cardiovascular system -- Central nervous system -- Respiratory system -- Renal function -- Gastrointestinal system -- Immune system
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| Abstract
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"This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs, 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 international especially Europe and Japan) and updated test methods, interpretation, and science"--Provided by publisher
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| Subject
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Drugs-- Toxicology
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Drugs-- Safety measures
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Drug development-- Safety measures
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Drug Evaluation, Preclinical
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Drug Approval
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Product Surveillance, Postmarketing
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Toxicity Tests
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| Dewey Classification
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615.7/04
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| LC Classification
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RA1238.G333 2012
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| NLM classification
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2012 F-386
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QV 771
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| Added Entry
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Gad, Shayne C.,1948-
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