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Documents Application of Toxicology Databases in Drug Development (Estimating potential toxicity)

Application of Toxicology Databases in Drug Development (Estimating potential toxicity) Joseph F. Contrera, Ph.D. Director, Regulatory Research and Analysis FDA Center for…

Documents Regulatory Framework for Phase I & Clinical Pharmacology Studies

Regulatory Framework for Phase I & Clinical Pharmacology Studies Funmilayo O. Ajayi, PhD, FCP, FIST Procter & Gamble Cincinnati, Ohio Talk Overview Background Information:…

Documents (NEW) ICH Guidelines Revised 2006

ICH, WHO, USFDA GUIDELINES ON STABILITY TESTING AND SHELF LIFE FOR INTERNATIONAL REGISTRATION OF PHARMACEUTICALS