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Frequentist and Bayesian tolerance intervals for setting specification limits for left-censored gamma distributed drug quality attributes.
Pharm Stat. 2024 Mar-Apr;23(2):168-184. doi: 10.1002/pst.2344. Epub 2023 Oct 23.
Pharm Stat. 2024.
PMID: 37871968
Simple Approach to Calculate Random Effects Model Tolerance Intervals to Set Release and Shelf-Life Specification Limits of Pharmaceutical Products.
Montes RO, Burdick RK, Leblond DJ.
Montes RO, et al.
PDA J Pharm Sci Technol. 2019 Jan-Feb;73(1):39-59. doi: 10.5731/pdajpst.2018.008839. Epub 2018 Oct 25.
PDA J Pharm Sci Technol. 2019.
PMID: 30361286
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Variation transmission model for setting acceptance criteria in a multi-staged pharmaceutical manufacturing process.
Montes RO.
Montes RO.
AAPS PharmSciTech. 2012 Mar;13(1):193-201. doi: 10.1208/s12249-011-9734-7. Epub 2011 Dec 23.
AAPS PharmSciTech. 2012.
PMID: 22193942
Free PMC article.
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Ex vivo fludarabine exposure inhibits graft-versus-host activity of allogeneic T cells while preserving graft-versus-leukemia effects.
Giver CR, Montes RO, Mittelstaedt S, Li JM, Jaye DL, Lonial S, Boyer MW, Waller EK.
Giver CR, et al. Among authors: montes ro.
Biol Blood Marrow Transplant. 2003 Oct;9(10):616-32. doi: 10.1016/s1083-8791(03)00229-5.
Biol Blood Marrow Transplant. 2003.
PMID: 14569558
Free article.
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