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In vivo models and decision trees for formulation development in early drug development: A review of current practices and recommendations for biopharmaceutical development.
Zane P, Gieschen H, Kersten E, Mathias N, Ollier C, Johansson P, Van den Bergh A, Van Hemelryck S, Reichel A, Rotgeri A, Schäfer K, Müllertz A, Langguth P. Zane P, et al. Among authors: schafer k. Eur J Pharm Biopharm. 2019 Sep;142:222-231. doi: 10.1016/j.ejpb.2019.06.010. Epub 2019 Jun 21. Eur J Pharm Biopharm. 2019. PMID: 31233862 Review.
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: schafer k. 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
IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 4: Prediction accuracy and software comparisons with improved data and modelling strategies.
Ahmad A, Pepin X, Aarons L, Wang Y, Darwich AS, Wood JM, Tannergren C, Karlsson E, Patterson C, Thörn H, Ruston L, Mattinson A, Carlert S, Berg S, Murphy D, Engman H, Laru J, Barker R, Flanagan T, Abrahamsson B, Budhdeo S, Franek F, Moir A, Hanisch G, Pathak SM, Turner D, Jamei M, Brown J, Good D, Vaidhyanathan S, Jackson C, Nicolas O, Beilles S, Nguefack JF, Louit G, Henrion L, Ollier C, Boulu L, Xu C, Heimbach T, Ren X, Lin W, Nguyen-Trung AT, Zhang J, He H, Wu F, Bolger MB, Mullin JM, van Osdol B, Szeto K, Korjamo T, Pappinen S, Tuunainen J, Zhu W, Xia B, Daublain P, Wong S, Varma MVS, Modi S, Schäfer KJ, Schmid K, Lloyd R, Patel A, Tistaert C, Bevernage J, Nguyen MA, Lindley D, Carr R, Rostami-Hodjegan A. Ahmad A, et al. Among authors: schafer kj. Eur J Pharm Biopharm. 2020 Nov;156:50-63. doi: 10.1016/j.ejpb.2020.08.006. Epub 2020 Aug 14. Eur J Pharm Biopharm. 2020. PMID: 32805361
Dissolution testing of modified release products with biorelevant media: An OrBiTo ring study using the USP apparatus III and IV.
Reppas C, Vrettos NN, Dressman J, Andreas CJ, Miyaji Y, Brown J, Etherson K, Hanley S, Karkossa F, Karlsson E, Klein S, Maier GM, McAllister M, Mistry N, Rosenblatt K, Schäfer KJ, Smith KL, Tomaszewska I, Williams J, Winge F, Vertzoni M. Reppas C, et al. Among authors: schafer kj. Eur J Pharm Biopharm. 2020 Nov;156:40-49. doi: 10.1016/j.ejpb.2020.08.025. Epub 2020 Aug 31. Eur J Pharm Biopharm. 2020. PMID: 32882421
918 results