Transcription of Shelf-Life Determination - IICAB Presentation
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Shelf-Life Determination - IICAB Presentation
Pharmaceutical shelf life Determination :Findings of the PQRI Stability shelf life Working GroupJames Schwenke, StatisticianApplied Research Consultants, LLCD etermining Release and Throughout Dating Potency Specifications:A Regulatory Policy WorkshopApril 21 22, 2015 Product Quality Research Institute (PQRI) Stability shelf life Working Group PERSPECTIVE The Working Group is comprised of members from the R&D pharmaceutical industry including Statisticians, CMC and regulatory affairs as well as academia and FDA. The Working Group has been together since 2006 with a core of original members. Past members still keep in touch, with new members being added, together contributing a variety of experiences, opinions and philosophies. The statistical issues presented and discussed throughout this Presentation are not dependent on species, product type or formulation. The statistical analysis is only dependent on the structure of the response data, where data are recorded from a set of registration batches or serials obtained under statistical control with each batch or serial independently measured over time.
ICH/FDA Guidance • ICH Q1E states “An appropriate approach to retest period or shelf life estimation is to analyze a quantitative attribute (e.g., assay,
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