Author	Gad, Shayne C., 1948-
Title	Safety pharmacology in pharmaceutical development : approval and post marketing surveillance / Shayne C. Gad
Imprint	Boca Raton, FL : CRC Press, c2012
Edition	2nd ed.
Descript	xv, 197 p. : ill. ; 24 cm

"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

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

1. Drugs -- Toxicology
2. Drugs -- Safety measures
3. Drug development -- Safety measures
4. Drug Evaluation
5. Preclinical
6. Drug Approval
7. Product Surveillance
8. Postmarketing
9. Toxicity Tests

LOCATION	CALL#	STATUS
Pharmaceutical Sciences Library	RA1238 G333S 2012	CHECK SHELVES