Fall 2000 Seminar Series - November 28, 2000
University of Minnesota
School of Statistics
College of Liberal Arts

Statistical Challenges in Clinical Pharmacology

Bret Musser
Statistician
Merck & Co., Rahway, NJ

Tuesday, November 28, 2000
4:00 PM, Vincent Hall
207 Minneapolis, East Bank Campus
Social at 3:30 PM, 300 Ford Hall

Abstract

When statisticians think about clinical trials and the drug development process, they usually think about Phase III clinical trials. However, clinical drug development is more than the classic large confirmatory trial. In clinical pharmacology, the fundamental biological aspects of potential new medicines are explored: how fast the drug is absorbed, how fast it is eliminated, how the drug might interact with other drugs, and more. For the statistician, these early stages of clinical development are often more exciting --- and more difficult --- than the classic Phase III clinical trial. This talk will present an overview of the drug development process and briefly discuss the phases of clinical development. After the general overview, several on-going statistical problems in clinical pharmacology will be presented. Bret Musser is a graduate from the School of Statistics. He currently works for pharmaceutical giant Merck & Co. in Rahway, NJ, as a statistician.