Using tolerance intervals for assessment of pharmaceutical quality

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Xiaoyu Dong1, Yi Tsong, Meiyu Shen

  • 1a Office of Biostatistics , /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring , Maryland , USA.

Journal of Biopharmaceutical Statistics
|October 31, 2014
PubMed

Keywords:
Acceptance criteriaCoverage hypothesisOne-sided tolerance intervalTwo one-sided testTwo-sided tolerance interval

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