Other Lecture or Seminar

A Statistician's Role in Drug Product Development

Dr. Kristi L. Griffiths
Eli Lilly & Company

Start Date and Time: Mon, 22 Oct 2001, 4:30 PM

End Date and Time: Mon, 22 Oct 2001, 6:00 PM

Venue: LAEB B222

Abstract:

The role of the statistician in the pharmaceutical development area is both challenging and diverse. In this area, the primary goal of statisticians is to work with chemists, formulators, and engineers to develop the product forms that are used in Phase I - III clinical trials and then passed on to the full scale manufacturing facilities. The development statisticians also work with analytical chemists in developing methods that test the product's ability to meet specific requirements for potency, rate of release, degradation product levels, and other measurable aspects throughout its intended shelf life. 

As statistical involvement in this area is not a regulatory requirement, development statisticians need to be effective sales persons to convince scientists of the value of using statistical methods. Statisticians provide consulting to a variety of clients during the drug development process in the areas of experimental design, variance components analysis, linear and nonlinear regression, and many other statistical applications. The statisticians supporting this area also provide many training courses throughout the year on experimental design, variance components, and basic statistics to increase the efficiency, effectiveness, and independence of the scientists they support. This talk will provide an overview of some of the issues faced by statisticians in the pharmaceutical development area and will introduce a case study to illustrate the types of projects worked on by pharmaceutical development statisticians.