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Current Practices in Shelf Life Estimation

Current Practices in Shelf Life EstimationJames SchwenkeBoehringer Ingelheim Pharmaceuticals, ,PQRI Stability Shelf Life Working GroupShelf Life Estimation ICH Estimation methods Typical stability study Shelf Life paradigm Regression methods for estimating Shelf life Actual stability study results Summarize empirical distribution of estimated Shelf life Extend to random batch analysesAugust 1, 2010 Pharmaceutical Stability Shelf Life1 ICH Guideline Q1A defines Shelf Life (also referred to as expiration dating period) as The Shelf life for a pharmaceutical product is the maximum time at which a stability limiting characteristic stays within acceptance criteria. p Also in Q1A, Specification Shelf Life is defined as The combination of physical, chemical biological, and microbiological tests and acceptance criteria that determine the suitability of a drug substance throughout its re-test period, or that a drug product should meet throughout its Shelf life.

• Random batch effects – the 0.25 level of significance used to test hypotheses involving fixed batch effects is intended to accommodate batch-to-batch variation – available software allows for random batch analysis – would avoid batch poolability issue Pharmaceutical Stability Shelf Life August 1, 2010 13 Real-Life Example Data Set

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