Statistical Applications in Pharmaceutical Research and Development Department of Statistics Purdue University Monday, October 29, 2001 4:30 PM in LAEB B222 Dr. Wherly Hoffman and Dr. Daniel Ness Eli Lilly & Company will speak on Statistics in Toxicology 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.

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