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Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series.
McAllister M, Flanagan T, Cole S, Abend A, Kotzagiorgis E, Limberg J, Mead H, Mangas-Sanjuan V, Dickinson PA, Moir A, Pepin X, Zhou D, Tistaert C, Dokoumetzidis A, Anand O, Le Merdy M, Turner DB, Griffin BT, Darwich A, Dressman J, Mackie C. McAllister M, et al. Among authors: turner db. Pharmaceutics. 2022 May 7;14(5):1010. doi: 10.3390/pharmaceutics14051010. Pharmaceutics. 2022. PMID: 35631595 Free PMC article.
PBPK models for the prediction of in vivo performance of oral dosage forms.
Kostewicz ES, Aarons L, Bergstrand M, Bolger MB, Galetin A, Hatley O, Jamei M, Lloyd R, Pepin X, Rostami-Hodjegan A, Sjögren E, Tannergren C, Turner DB, Wagner C, Weitschies W, Dressman J. Kostewicz ES, et al. Among authors: turner db. Eur J Pharm Sci. 2014 Jun 16;57:300-21. doi: 10.1016/j.ejps.2013.09.008. Epub 2013 Sep 21. Eur J Pharm Sci. 2014. PMID: 24060672 Review.
Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen.
Loisios-Konstantinidis I, Cristofoletti R, Fotaki N, Turner DB, Dressman J. Loisios-Konstantinidis I, et al. Among authors: turner db. Eur J Pharm Sci. 2020 Feb 15;143:105170. doi: 10.1016/j.ejps.2019.105170. Epub 2019 Nov 27. Eur J Pharm Sci. 2020. PMID: 31783158
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: turner db. 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 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. 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
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