KEYNOTE SPEECH II
Clinical Pharmacology in Drug Development
Clinical pharmacology plays an important role in drug development, especially in determining the optimal dosage regimen. This involves the evaluation of the drug’s pharmacokinetics and pharmacodynamics, food effect, drug interaction potential, bioanalysis, exposure-response relationship for safety and efficacy, and considerations when being used in specific populations.
Case examples will be presented to highlight the utility and importance of clinical pharmacology in drug development to ensure that drug products are safe and effective and that they are delivered in the right dose, at the right time, to the right patient.
Chongwoo Yu, Ph.D., Office of Clinical Pharmacology,
Office of Translational Sciences, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Dr. Yu is a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug Administration (FDA). Dr. Yu received his Ph.D. in Analytical Chemistry with the focus on Drug Metabolism and Mass Spectrometry from the University of Illinois at Chicago.
Subsequently, Dr. Yu has worked in the Department of Pharmacokinetics, Dynamics, and Metabolism (PDM) at Pfizer (Ann Arbor, MI) and the Drug Metabolism and Pharmacokinetics (DMPK) Department at Schering-Plough (currently Merck; Kenilworth, NJ) for several years. At both organizations, Dr. Yu has been heavily involved in carrying out various types of drug metabolism, pharmacokinetics, and drug-drug interaction studies using mass spectrometry.
Since 2007 when Dr. Yu first joined the Agency, Dr. Yu’s work has been focused on the evaluation of bone, reproductive, and urologic drug products. Dr. Yu served as the Principal Investigator of FDA sponsored research projects including: (1) Effect of Body Mass Index / Body Weight on Effectiveness of Hormonal Contraceptive Products for Women, and (2) Investigation of Drug-Drug Interactions with Hormonal Contraceptives. Dr. Yu served as a member of FDA guidance working groups including those for the Bioanalytical Method Validation Guidance, Clinical Combined Oral Contraceptive Drug Interaction Guidance, and the Labeling for Combined Oral Contraceptives Guidance.
Dr. Yu currently serves as the chair of the FDA OCP Bioanalytical Research (BAR) Scientific Interest Group (SIG).