approval and post marketing surveillance Gad, Shayne C. 1948- creator text bibliography Electronic books. flu Boca Raton, Fla CRC Press 2012 2nd ed. monographic eng

electronic

electronic resource

application/PDF xv, 197 p. : ill. "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. 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. Shayne C. Gad. Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004. Includes bibliographical references and index. Also available in print edition. Mode of access: World Wide Web. Drug development Drug approval Pharmacology Gad, Shayne C., 1948- 9781439845684 (ebook : PDF) http://marc.crcnetbase.com/isbn/9781439845684 http://marc.crcnetbase.com/isbn/9781439845684 BD-DhSAU 120530 20151012144305.0 CRC0KE12014PDF