00000cam a22000004a 4500 UP-1685523046126236881 Buklod 20130124165035.0 m |o d | ta 130124s2012 xx d r |||| u| 9781439845677 (iLib)UPMNL-00012617526 Ph-8570 Forefront Php10213.00 UPPharm eng RA 1238 G333 2012 Gad, Shayne C. 1948- Safety pharmacology in pharmaceutical development approval and post marketing surveillance Shayne C. Gad. 2nd edition. Boca Raton, FL CRC Press c2012. xv, 197 pages illustrations 24 cm. text rdacontent unmediated rdamedia volume rdacarrier Rev. ed. of: Safety pharmacology in pharmaceutical development and approval. c2004. Includes bibliographical references and index. 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. "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. Drugs Toxicology. Drugs Safety measures. Drug development Safety measures. Drug Evaluation, Preclinical. Drug Approval. Product Surveillance, Postmarketing. Toxicity Tests. Gad, Shayne C. 1948- Safety pharmacology in pharmaceutical development and approval. FO UPMNL PHARM RA 1238 G333 2012 Book