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Industry's View on Using Quality Control, Biorelevant, and Clinically Relevant Dissolution Tests for Pharmaceutical Development, Registration, and Commercialization.
Grady H, Elder D, Webster GK, Mao Y, Lin Y, Flanagan T, Mann J, Blanchard A, Cohen MJ, Lin J, Kesisoglou F, Hermans A, Abend A, Zhang L, Curran D. Grady H, et al. Among authors: mann j. J Pharm Sci. 2018 Jan;107(1):34-41. doi: 10.1016/j.xphs.2017.10.019. Epub 2017 Oct 24. J Pharm Sci. 2018. PMID: 29074376 Review.
In vitro models for the prediction of in vivo performance of oral dosage forms.
Kostewicz ES, Abrahamsson B, Brewster M, Brouwers J, Butler J, Carlert S, Dickinson PA, Dressman J, Holm R, Klein S, Mann J, McAllister M, Minekus M, Muenster U, Müllertz A, Verwei M, Vertzoni M, Weitschies W, Augustijns P. Kostewicz ES, et al. Among authors: mann j. Eur J Pharm Sci. 2014 Jun 16;57:342-66. doi: 10.1016/j.ejps.2013.08.024. Epub 2013 Aug 27. Eur J Pharm Sci. 2014. PMID: 23988843 Free article. Review.
Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.
Mann J, Dressman J, Rosenblatt K, Ashworth L, Muenster U, Frank K, Hutchins P, Williams J, Klumpp L, Wielockx K, Berben P, Augustijns P, Holm R, Hofmann M, Patel S, Beato S, Ojala K, Tomaszewska I, Bruel JL, Butler J. Mann J, et al. Mol Pharm. 2017 Dec 4;14(12):4192-4201. doi: 10.1021/acs.molpharmaceut.7b00198. Epub 2017 Aug 23. Mol Pharm. 2017. PMID: 28737403
In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration.
Butler J, Hens B, Vertzoni M, Brouwers J, Berben P, Dressman J, Andreas CJ, Schaefer KJ, Mann J, McAllister M, Jamei M, Kostewicz E, Kesisoglou F, Langguth P, Minekus M, Müllertz A, Schilderink R, Koziolek M, Jedamzik P, Weitschies W, Reppas C, Augustijns P. Butler J, et al. Among authors: mann j. Eur J Pharm Biopharm. 2019 Mar;136:70-83. doi: 10.1016/j.ejpb.2018.12.010. Epub 2018 Dec 20. Eur J Pharm Biopharm. 2019. PMID: 30579851 Free article.
Biorelevant dissolution testing of a weak base: Interlaboratory reproducibility and investigation of parameters controlling in vitro precipitation.
Berben P, Ashworth L, Beato S, Bevernage J, Bruel JL, Butler J, Dressman J, Schäfer K, Hutchins P, Klumpp L, Mann J, Nicolai J, Ojala K, Patel S, Powell S, Rosenblatt K, Tomaszewska I, Williams J, Augustijns P. Berben P, et al. Among authors: mann j. Eur J Pharm Biopharm. 2019 Jul;140:141-148. doi: 10.1016/j.ejpb.2019.04.017. Epub 2019 Apr 30. Eur J Pharm Biopharm. 2019. PMID: 31051249
3,957 results