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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: flanagan t. Pharmaceutics. 2022 May 7;14(5):1010. doi: 10.3390/pharmaceutics14051010. Pharmaceutics. 2022. PMID: 35631595 Free PMC article.
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
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