Other Lecture or Seminar

Statistics in Toxicology

Dr. Wherly Hoffman and Dr. Daniel Ness
Eli Lilly & Company

Start Date and Time: Mon, 29 Oct 2001, 4:30 PM

End Date and Time: Mon, 29 Oct 2001, 6:00 PM

Venue: LAEB B222

Abstract:

Toxicology plays an important role in the safety assessment of pharmaceuticals. Statistics is an integral part of toxicology studies. The purpose of this presentation is to provide the audience with an overall understanding of the rationale for toxicology studies and how the results enter into the design of clinical studies. Therefore the design, analysis, and interpretation of these studies will be discussed. A brief introduction to the design considerations of repeat dose studies, including species selection, number of animals, route of administration, parameters of interest, and timing of data collection will be presented from a toxicological perspective. The focus of the presentation, however, will be on analysis methods, power, Type I error rate, and evaluation/interpretation of toxicity from a statistical perspective. Examples of applications of statistical methods to toxicology studies will be included.