Dose Finding is a critical part in drug development. Traditionally, chronic disease and oncology development has distinct approach for dose finding. This tutorial will give an overview of the overall dose-finding process in both areas, and discuss the emerging trends. Different approaches for hypothesis testing of proof of concept and modeling in dose finding studies will be introduced at a high level, and demonstrated by examples. Pragmatic recommendations on dose range, number of doses, dose spacing and formulation will be given with supportive data and evidence. The instructor will also give her opinion and recommendations on the way to apply adaptive design elements within dose finding studies.
Dr. Qiqi Deng is a Senior principle Biostatistician at Boehringer Ingelheim Pharmaceutical. She is currently a member of the Methodology Expert team within global statistics, which focuses on statistical methodology innovation. Her research area includes hypothesis and modeling in dose finding, pragmatic considerations in designing dose finding trials, including adaptive design aspects. Before she joined the methodology group, she has served as leading statistician for multiple projects, across different clinical development phases and therapeutic areas. Dr. Deng received her bachelorís degree in Mathematics from Peking University in China, and obtained her Ph. D. in Statistics from University of Minnesota.