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Journal of Biopharmaceutical Statistics Volume 25, 2015 - Issue 2: Recent Developments in Statistical Approaches for Chemistry and Manufacturing Control (CMC) and Quality-by-Design (QbD)
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Original Articles

Using Tolerance Intervals for Assessment of Pharmaceutical Quality

Xiaoyu DongOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
,
Yi TsongOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
,
Meiyu ShenOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
&
Jinglin ZhongOffice of Biostatistics, /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA
Pages 317-327 | Received 29 Sep 2014, Accepted 30 Sep 2014, Published online: 25 Feb 2015

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