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Risk-Based Approach to Lot Release

Linas Mockus1, Gintaras Reklaitis1, Kenneth Morris2

  • 1Davidson School of Chemical Engineering, Purdue University, West Lafayette, Indiana 47907-2100.

Journal of Pharmaceutical Sciences
|October 15, 2019
PubMed

Keywords:
Bayesian methodsUSP monographsadaptive samplingin vitro dissolutioninter-lot variabilitylot releasepharmaceutical manufacturingprior knowledgerisk-based decision makingunit dose uniformity

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