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Evaluating the performance of the ICH guidelines for shelf life estimation

Michelle Quinlan1, Walter Stroup, James Schwenke

  • 1Novartis Oncology, Florham Park, NJ 07932, USA. mquinlan22@yahoo.com

Journal of Biopharmaceutical Statistics
|June 22, 2013
PubMed
Summary

Shelf life estimation needs improvement. Current guidelines have issues, suggesting random batch effects and quantile focus for more accurate product shelf life determination applicable to all future batches.

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