Other Lecture or Seminar

Clinical Pharmacology Statistics

Dr. Brian Smith
Eli Lilly & Company

Start Date and Time: Mon, 24 Sep 2001, 4:30 PM

End Date and Time: Mon, 24 Sep 2001, 6:00 PM

Venue: LAEB B222

Abstract:

Clinical pharmacology is an area of medicine concerned with delivering the correct dose of a compound to a particular patient. In drug development, clinical pharmacology also contains Phase 1 development. Phase 1 studies have two primary goals, as well as many secondary goals. The first primary goal is to find acute safety concerns with the compound being studied. The second primary goal is to recommend doses that will optimize the chance of successful Phase 2 studies (early efficacy studies). If Phase 2 studies result in encouraging efficacy and safety information, then clinical pharmacology initiates a host of activities in order to demonstrate whether dosage adjustments are necessary. Such studies as drug interaction studies, bioequivalence, and special population studies are part of this effort. In all clinical pharmacology studies use of pharmacokinetic and pharmacodynamic (to be defined in the talk) information is needed to accomplish its aims. Most clinical pharmacology studies are performed in healthy subjects. Most have small sample sizes, with crossover and repeated measures components, which presents interesting challenges to the statistical scientist. In addition to classical clinical pharmacology studies, pharmacokinetic information is captured in many Phase 2 and 3 studies. Analysis of this data with non-linear mixed effect models can lead to a better understanding of patient specific covariates, which may lead to dosage adjustments.