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

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 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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vol. 73 no. 1 39-59

DOI

https://doi.org/10.5731/pdajpst.2018.008839

PubMed

30361286

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

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Published online February 1, 2019.

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previous version (October 25, 2018 - 06:38).
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Author Information

Richard O. Montes1,*,
Richard K. Burdick2 and
David J. Leblond3

¹Pfizer, Lake Forest, Illinois, USA;
²Burdick Statistical Consulting, Louisville, Colorado, USA; and
³CMCStats, Wadsworth, Illinois, USA

↵* Corresponding Author: Pfizer, 375 N, Field Drive, H3-3N 3-3209, Lake Forest, IL 60045, USA. E-mail: richard.montes{at}pfizer.com

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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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