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Current status and future opportunities for incorporation of dissolution data in PBPK modeling for pharmaceutical development and regulatory applications: OrBiTo consortium commentary.
Jamei M, Abrahamsson B, Brown J, Bevernage J, Bolger MB, Heimbach T, Karlsson E, Kotzagiorgis E, Lindahl A, McAllister M, Mullin JM, Pepin X, Tistaert C, Turner DB, Kesisoglou F. Jamei M, et al. Among authors: brown j. Eur J Pharm Biopharm. 2020 Oct;155:55-68. doi: 10.1016/j.ejpb.2020.08.005. Epub 2020 Aug 8. Eur J Pharm Biopharm. 2020. PMID: 32781025 Review.
IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3: Identifying gaps in system parameters by analysing In Silico performance across different compound classes.
Darwich AS, Margolskee A, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B. Darwich AS, et al. Among authors: brown j. Eur J Pharm Sci. 2017 Jan 1;96:626-642. doi: 10.1016/j.ejps.2016.09.037. Epub 2016 Sep 28. Eur J Pharm Sci. 2017. PMID: 27693299
IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results.
Margolskee A, Darwich AS, Pepin X, Aarons L, Galetin A, Rostami-Hodjegan A, Carlert S, Hammarberg M, Hilgendorf C, Johansson P, Karlsson E, Murphy D, Tannergren C, Thörn H, Yasin M, Mazuir F, Nicolas O, Ramusovic S, Xu C, Pathak SM, Korjamo T, Laru J, Malkki J, Pappinen S, Tuunainen J, Dressman J, Hansmann S, Kostewicz E, He H, Heimbach T, Wu F, Hoft C, Laplanche L, Pang Y, Bolger MB, Huehn E, Lukacova V, Mullin JM, Szeto KX, Costales C, Lin J, McAllister M, Modi S, Rotter C, Varma M, Wong M, Mitra A, Bevernage J, Biewenga J, Van Peer A, Lloyd R, Shardlow C, Langguth P, Mishenzon I, Nguyen MA, Brown J, Lennernäs H, Abrahamsson B. Margolskee A, et al. Among authors: brown j. Eur J Pharm Sci. 2017 Jan 1;96:610-625. doi: 10.1016/j.ejps.2016.10.036. Epub 2016 Nov 2. Eur J Pharm Sci. 2017. PMID: 27816631
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: brown j. 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: brown j. 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
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