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.
Pharmaceutical Shelf Life Determination: Findings of the PQRI Stability Shelf Life Working Group James Schwenke, Ph.D. Consulting Statistician
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