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Research ArticleResearch

Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products

Richard O. Montes, Richard K. Burdick and David J. Leblond
PDA Journal of Pharmaceutical Science and Technology January 2019, 73 (1) 39-59; DOI: https://doi.org/10.5731/pdajpst.2018.008839
Richard O. Montes
1Pfizer, Lake Forest, Illinois, USA;
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  • For correspondence: richard.montes@pfizer.com
Richard K. Burdick
2Burdick Statistical Consulting, Louisville, Colorado, USA; and
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David J. Leblond
3CMCStats, Wadsworth, Illinois, USA
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PDA Journal of Pharmaceutical Science and Technology: 73 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 1
January/February 2019
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Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products
Richard O. Montes, Richard K. Burdick, David J. Leblond
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 39-59; DOI: 10.5731/pdajpst.2018.008839

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Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products
Richard O. Montes, Richard K. Burdick, David J. Leblond
PDA Journal of Pharmaceutical Science and Technology Jan 2019, 73 (1) 39-59; DOI: 10.5731/pdajpst.2018.008839
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Keywords

  • Bayesian posterior predictive
  • generalized pivotal quantity
  • random effects model
  • release and shelf-life specification limits
  • Tolerance interval

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