Pharmaceutical Product Development (PDF)

DAKSHINA MURTHY CHILUKURI is a Senior Reviewer in the Office of Clinical Pharmacology, U.S. Food and Drug Administration (FDA), Silver Spring, Maryland. He is responsible for review of clinical pharmacology-related information in Investigational New Drug Applications (IND) and New Drug Applications (NDA). Previously he has held positions in industry in the areas of design, analysis, and interpretation of pharmacokinetic studies, developing in vitro-in vivo correlation from various dosage forms, and serving as a consultant for pharmaceutical and biotechnology companies working in formulation development, preclinical development, and IND filing. Dr. Chilukuri received the B.Pharm. degree from Kakatiya University, Warangal, India and the Ph.D. degree in pharmaceutical sciences from Medical University of South Carolina, Charleston. GANGADHAR SUNKARA is Associate Director, Pharmacokinetics, Exploratory Development, Novartis Pharmaceuticals, East Hanover, New Jersey. Dr. Sunkara is the author of numerous peer-reviewed scientific publications, presenter at over 20 international scientific meetings, and recipient of the AAPS Graduate Symposium Award in Drug Delivery and Pharmaceutical Technology (2001). He received the B. Pharm. degree and the M. Pharm. degree in pharmaceutics from Kakatiya University, Warangal, India, the Ph.D. degree from the University of Nebraska Medical Center, Omaha, and the M.B.A. degree in finance from Fairleigh-Dickinson University, Madison, New Jersey. DAVID YOUNG is President, U.S. Operations, AGI Therapeutics, Inc., Columbia, Maryland. Before joining AGI, Dr. Young founded GloboMax, and became Executive Vice President of the GloboMax Division of ICON plc, Hanover, Maryland, after his company was acquired by ICON plc. Prior to forming GloboMax, he had a distinguished career in academia, serving as Associate Professor in the Department of Pharmaceutical Sciences and the Managing Director of the Clinical Research Unit at the University of Maryland,

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