Safety pharmacology in pharmaceutical development [electronic resource] : approval and post marketing surveillance / Shayne C. Gad.
By: Gad, Shayne C.
Contributor(s): Gad, Shayne C. Safety pharmacology in pharmaceutical development and approval.
Material type:
BookPublisher: Boca Raton, Fla. : CRC Press, 2012Edition: 2nd ed.Description: xv, 197 p. : ill.ISBN: 9781439845684 (ebook : PDF).Subject(s): Drug development | Drug approval | PharmacologyGenre/Form: Electronic books.Additional physical formats: No titleOnline resources: Distributed by publisher. Purchase or institutional license may be required for access. Also available in print edition.Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004.
Includes bibliographical references and index.
ch. 1. Safety pharmacology : background, history, issues, and concerns -- ch. 2. Regulatory requirements : ICH, FDA, EMA, and Japan -- ch. 3. Principles of screening and study design -- ch. 4. Cardiovascular system -- ch. 5. Central nervous system -- ch. 6. Respiratory system -- ch. 7. Renal function -- ch. 8. The gastrointestinal system -- ch. 9. The immune system.
"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.
Also available in print edition.
Mode of access: World Wide Web.
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