A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity. Part 1—Characterization of FDA Proposed Test

AAPS PharmSciTech - Tập 10 Số 3 - 2009
Steven Novick1, David Christopher2, Monisha Dey2, Svetlana Lyapustina3, Michael A. Golden4, Stefan Leiner5, Bruce Wyka6, Hans-Joachim Delzeit5, Chris Novak7, Gregory Larner8
1Discovery Analytics, GlaxoSmithKline, Research Triangle Park, North Carolina, USA
2Statistics, Schering-Plough Research Institute, Kenilworth, New Jersey, USA
3Pharmaceutical Practice Group, Drinker Biddle & Reath, 1500 K Street NW, Suite 1100, Washington, District of Colombia, 20005-1209, USA
4Regulatory Affairs and Quality, Pearl Therapeutics, Raleigh, North Carolina, USA
5Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany
6SpiraPharma Consulting, Lincoln Park, New Jersey, USA
7Lab Services Department, Drug Delivery Systems Division, 3M, St. Paul, Minnesota, USA
8Scientific and Laboratory Services, Pfizer, Kalamazoo, Michigan, USA

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