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Bayesian statistical approaches to drug product variability assessment and release.
Cai Q, Mockus L, LeBlond D, Sun X, Wei H, Shah HS, Chaturvedi K, Sardhara R, Nahar K, Khalil R, Sharma A, Rutesh D, Joglekar G, Reklaitis G, Morris K. Cai Q, et al. Among authors: leblond d. Int J Pharm. 2022 Aug 25;624:122037. doi: 10.1016/j.ijpharm.2022.122037. Epub 2022 Jul 21. Int J Pharm. 2022. PMID: 35870665 Review.
Risk-Based Approach to Lot Release.
Mockus L, Reklaitis G, Morris K, LeBlond D. Mockus L, et al. Among authors: leblond d. J Pharm Sci. 2020 Feb;109(2):1035-1042. doi: 10.1016/j.xphs.2019.10.011. Epub 2019 Oct 11. J Pharm Sci. 2020. PMID: 31610180
Evaluating Current Practices in Shelf Life Estimation.
Capen R, Christopher D, Forenzo P, Huynh-Ba K, LeBlond D, Liu O, O'Neill J, Patterson N, Quinlan M, Rajagopalan R, Schwenke J, Stroup W. Capen R, et al. Among authors: leblond d. AAPS PharmSciTech. 2018 Feb;19(2):668-680. doi: 10.1208/s12249-017-0880-4. Epub 2017 Sep 25. AAPS PharmSciTech. 2018. PMID: 28948584
Testing assay linearity over a pre-specified range.
Yang H, Novick SJ, LeBlond D. Yang H, et al. Among authors: leblond d. J Biopharm Stat. 2015;25(2):339-50. doi: 10.1080/10543406.2014.972513. J Biopharm Stat. 2015. PMID: 25356663
Timing of Red Blood Cell Transfusions and Occurrence of Necrotizing Enterocolitis: A Secondary Analysis of a Randomized Clinical Trial.
Salas AA, Gunn E, Carlo WA, Bell EF, Das A, Josephson CD, Patel RM, Tan S, Kirpalani H; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network. Salas AA, et al. JAMA Netw Open. 2024 May 1;7(5):e249643. doi: 10.1001/jamanetworkopen.2024.9643. JAMA Netw Open. 2024. PMID: 38700862 Free PMC article. Clinical Trial.
44 results