Other Statistics and Probability Commons^™

Evaluating Current Practices In Shelf Life Estimation, Robert Capen, David Christopher, Patrick Forenzo, Kim Huynh-Ba, David Leblond, Oscar Liu, John O'Neill, Nate Patterson, Michelle Quinlan, Radhika Rajagopalan, James Schwenke, Walter W. Stroup

Department of Statistics: Faculty Publications

The current International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) methods for determining the supported shelf life of a drug product, described in ICH guidance documents Q1A and Q1E, are evaluated in this paper. To support this evaluation, an industry data set is used which is comprised of 26 individual stability batches of a common drug product where most batches are measured over a 24 month storage period. Using randomly sampled sets of 3 or 6 batches from the industry data set, the current ICH methods are assessed from three perspectives. First, the distributional properties …