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Page 1
Potency assignment of biotherapeutic reference standards.
J Pharm Biomed Anal. 2020 Nov 30;191:113577. doi: 10.1016/j.jpba.2020.113577. Epub 2020 Aug 24.
J Pharm Biomed Anal. 2020.
PMID: 32891042
A curve similarity approach to parallelism testing in bioassay.
Faya P, Rauk AP, Griffiths KL, Parekh B.
Faya P, et al.
J Biopharm Stat. 2020 Jul 3;30(4):721-733. doi: 10.1080/10543406.2020.1730875. Epub 2020 Mar 12.
J Biopharm Stat. 2020.
PMID: 32163316
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Stability analysis using mixed models: A critique of tolerance interval methods and a probabilistic solution.
Altan S, Faya P, Rauk AP, LeBlond D, Seaman JW Jr, Banton D.
Altan S, et al. Among authors: faya p.
Pharm Stat. 2023 Sep-Oct;22(5):784-796. doi: 10.1002/pst.2305. Epub 2023 May 10.
Pharm Stat. 2023.
PMID: 37164770
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Using accelerated drug stability results to inform long-term studies in shelf life determination.
Faya P, Seaman JW Jr, Stamey JD.
Faya P, et al.
Stat Med. 2018 Jul 30;37(17):2599-2615. doi: 10.1002/sim.7663. Epub 2018 May 15.
Stat Med. 2018.
PMID: 29766536
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Bayesian assurance and sample size determination in the process validation life-cycle.
Faya P, Seaman JW Jr, Stamey JD.
Faya P, et al.
J Biopharm Stat. 2017;27(1):159-174. doi: 10.1080/10543406.2016.1148717. Epub 2016 Feb 18.
J Biopharm Stat. 2017.
PMID: 26891342
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The current state of Bayesian methods in nonclinical pharmaceutical statistics: Survey results and recommendations from the DIA/ASA-BIOP Nonclinical Bayesian Working Group.
Faya P, Sondag P, Novick S, Banton D, Seaman JW Jr, Stamey JD, Boulanger B.
Faya P, et al.
Pharm Stat. 2021 Mar;20(2):245-255. doi: 10.1002/pst.2072. Epub 2020 Oct 6.
Pharm Stat. 2021.
PMID: 33025743
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A Bayesian Approach to Determination of F, D, and Z Values Used in Steam Sterilization Validation.
Faya P, Stamey JD, Seaman JW Jr.
Faya P, et al.
PDA J Pharm Sci Technol. 2017 Mar-Apr;71(2):88-98. doi: 10.5731/pdajpst.2016.006981. Epub 2016 Oct 27.
PDA J Pharm Sci Technol. 2017.
PMID: 27789802
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