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An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies.
Morar-Mitrica S, Adams ML, Crotts G, Wurth C, Ihnat PM, Tabish T, Antochshuk V, DiLuzio W, Dix DB, Fernandez JE, Gupta K, Fleming MS, He B, Kranz JK, Liu D, Narasimhan C, Routhier E, Taylor KD, Truong N, Stokes ESE. Morar-Mitrica S, et al. Among authors: stokes ese. J Pharm Sci. 2018 Feb;107(2):529-542. doi: 10.1016/j.xphs.2017.10.017. Epub 2017 Oct 23. J Pharm Sci. 2018. PMID: 29074375
An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations.
Halley J, Chou YR, Cicchino C, Huang M, Sharma V, Tan NC, Thakkar S, Zhou LL, Al-Azzam W, Cornen S, Gauden M, Gu Z, Kar S, Lazar AC, Mehndiratta P, Smith J, Sosic Z, Weisbach P, Stokes ESE. Halley J, et al. Among authors: stokes ese. J Pharm Sci. 2020 Jan;109(1):6-21. doi: 10.1016/j.xphs.2019.09.018. Epub 2019 Sep 26. J Pharm Sci. 2020. PMID: 31563512
An Intercompany Perspective on Compatibility and In-use Stability Studies to Enable Administration Of Biopharmaceutical Drug Products.
Kamen DE, Crotts G, Narasimhan C, Hu Q, Bhargava AC, Muthurania K, Burton L, Gbormittah FO, Mathews L, Mills B, Hodge T, Saluja S, Singh SN, Tabish T, Wu Y, Stokes ESE. Kamen DE, et al. Among authors: stokes ese. J Pharm Sci. 2022 Apr;111(4):1092-1103. doi: 10.1016/j.xphs.2021.09.043. Epub 2021 Sep 30. J Pharm Sci. 2022. PMID: 34600941
14 results