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Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A. Mitra A, et al. Among authors: flanagan t. J Pharm Sci. 2021 Feb;110(2):594-609. doi: 10.1016/j.xphs.2020.10.059. Epub 2020 Nov 3. J Pharm Sci. 2021. PMID: 33152375
In vivo methods for drug absorption - comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects.
Sjögren E, Abrahamsson B, Augustijns P, Becker D, Bolger MB, Brewster M, Brouwers J, Flanagan T, Harwood M, Heinen C, Holm R, Juretschke HP, Kubbinga M, Lindahl A, Lukacova V, Münster U, Neuhoff S, Nguyen MA, Peer Av, Reppas C, Hodjegan AR, Tannergren C, Weitschies W, Wilson C, Zane P, Lennernäs H, Langguth P. Sjögren E, et al. Among authors: flanagan t. Eur J Pharm Sci. 2014 Jun 16;57:99-151. doi: 10.1016/j.ejps.2014.02.010. Epub 2014 Mar 15. Eur J Pharm Sci. 2014. PMID: 24637348 Review.
Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.
Dickinson PA, Kesisoglou F, Flanagan T, Martinez MN, Mistry HB, Crison JR, Polli JE, Cruañes MT, Serajuddin ATM, Müllertz A, Cook JA, Selen A. Dickinson PA, et al. Among authors: flanagan t. J Pharm Sci. 2016 Nov;105(11):3243-3255. doi: 10.1016/j.xphs.2016.07.024. Epub 2016 Sep 19. J Pharm Sci. 2016. PMID: 27659159 Review.
In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.
Lennernäs H, Lindahl A, Van Peer A, Ollier C, Flanagan T, Lionberger R, Nordmark A, Yamashita S, Yu L, Amidon GL, Fischer V, Sjögren E, Zane P, McAllister M, Abrahamsson B. Lennernäs H, et al. Among authors: flanagan t. Mol Pharm. 2017 Apr 3;14(4):1307-1314. doi: 10.1021/acs.molpharmaceut.6b00824. Epub 2017 Mar 1. Mol Pharm. 2017. PMID: 28195732
A survey on IVIVC/IVIVR development in the pharmaceutical industry - Past experience and current perspectives.
Nguyen MA, Flanagan T, Brewster M, Kesisoglou F, Beato S, Biewenga J, Crison J, Holm R, Li R, Mannaert E, McAllister M, Mueller-Zsigmondy M, Muenster U, Ojala K, Page S, Parr A, Rossenu S, Timmins P, Van Peer A, Vermeulen A, Langguth P. Nguyen MA, et al. Among authors: flanagan t. Eur J Pharm Sci. 2017 May 1;102:1-13. doi: 10.1016/j.ejps.2017.02.029. Epub 2017 Feb 21. Eur J Pharm Sci. 2017. PMID: 28235611 Review.
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: flanagan t. 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.
344 results