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Drug safety evaluation

Drug Safety Evaluation. Second Edition. Shayne Cox Gad. The updated and expanded safety guide to all aspects of the drug development process. Drug Safety Evaluation, Second Edition presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics...

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Bibliographic Details
Main Authors: Gad, Shayne C., 1948
Corporate Authors: Wiley Online Library; Wiley InterScience Online service
Published:
Literature type: Electronic eBook
Language: English
Edition: 2nd ed.
Series: Pharmaceutical Development Series
Subjects:
Drugs > Toxicology
Drugs > Testing
Arzneimittelsicherheit
Drug Evaluation, Preclinical
Drug Evaluation
Product Surveillance, Postmarketing
MEDICAL > Drug Guides
MEDICAL > Nursing > Pharmacology
MEDICAL > Pharmacology
MEDICAL > Pharmacy
Electronic books
Online Access: http://onlinelibrary.wiley.com/book/10.1002/9780470464151
Summary: Drug Safety Evaluation. Second Edition. Shayne Cox Gad. The updated and expanded safety guide to all aspects of the drug development process. Drug Safety Evaluation, Second Edition 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. This Second Edition has been extensively revised and expanded to respond to the many changes in regulatory
Carrier Form: 1 online resource (xi, 1182 p.) : ill.
Bibliography: Includes bibliographical references and index.
ISBN: 9780470464151 (electronic bk.)
0470464151 (electronic bk.)
0470253169 (Cloth)
9780470253168 (Cloth)
9780470464090 (electronic bk.)
0470464097 (electronic bk.)
Index Number: RA1238
CLC: R991
Contents: Front Matter -- Drug Development Process and Global Pharmaceutical Marketplace -- Regulation of Human Pharmaceutical Safety -- Prior Art and Its Use in Safety Assessment Process -- Screens in Safety and Hazard Assessment -- Formulations, Routes, and Dosage Design -- Single-Dose (Acute) and Pilot (DRF) Toxicity Testing in Drug Safety Evaluation -- Genotoxicity -- Repeat-Dose Toxicity Studies -- Immunotoxicology in Drug Development -- Nonrodent Animal Studies -- Developmental and Reproductive Toxicity Testing -- Carcinogenicity Studies -- Histopathology in Nonclinical Pharmaceutical Safety Ass

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