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Best practices in bioassay development to support registration of biopharmaceuticals.
White JR, Abodeely M, Ahmed S, Debauve G, Johnson E, Meyer DM, Mozier NM, Naumer M, Pepe A, Qahwash I, Rocnik E, Smith JG, Stokes ES, Talbot JJ, Wong PY. White JR, et al. Among authors: stokes es. Biotechniques. 2019 Sep;67(3):126-137. doi: 10.2144/btn-2019-0031. Epub 2019 Aug 5. Biotechniques. 2019. PMID: 31379198 Free article.
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 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
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 industry perspective approach and control strategy for implementation of ready-to-use cells in bioassays: survey outcome and recommendations.
White JR, Ahmed S, Amstrup J, Bennington P, Cheng ZJ, Day P, Haenssen KK, Kozminsky-Atias A, Martinez E, Ong EH, Qahwash I, Stokes ES, Wang J. White JR, et al. Among authors: stokes es. Biotechniques. 2024 Apr;76(4):135-144. doi: 10.2144/btn-2023-0086. Epub 2024 Feb 9. Biotechniques. 2024. PMID: 38334496 Free article.
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