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.
ICH/FDA Guidance • ICH Guideline Q1E defines shelf life as “The shelf life of a pharmaceutical product is the maximum time at which the true mean response of a stability limiting
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