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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 October 2018, pdajpst.2018.008839; DOI: https://doi.org/10.5731/pdajpst.2018.008839

Article Information

pdajpst.2018.008839
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
History 
  • Received March 21, 2018
  • Accepted August 27, 2018
  • Published online October 25, 2018.

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Copyright & Usage 
Copyright © 2018, Parenteral Drug Association

Author Information

  1. Richard O Montes1,4 (richard.montes{at}pfizer.com),
  2. Richard K Burdick2 (rickbasu{at}aol.com) and
  3. David J LeBlond3 (david.leblond{at}sbcglobal.net)
  1. 1 Hospira, a Pfizer company;
  2. 2 Elion Labs;
  3. 3 CMCStats
  1. ↵* Corresponding author; email: 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 Oct 2018, pdajpst.2018.008839; DOI: 10.5731/pdajpst.2018.008839
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