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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: cole s. Pharmaceutics. 2022 May 7;14(5):1010. doi: 10.3390/pharmaceutics14051010. Pharmaceutics. 2022. PMID: 35631595 Free PMC article.
Commentary on the MID3 Good Practices Paper.
Manolis E, Brogren J, Cole S, Hay JL, Nordmark A, Karlsson KE, Lentz F, Benda N, Wangorsch G, Pons G, Zhao W, Gigante V, Serone F, Standing JF, Dokoumetzidis A, Vakkilainen J, van den Heuvel M, Mangas Sanjuan V, Taminiau J, Kerwash E, Khan D, Musuamba FT, Skottheim Rusten I; EMA Modelling and Simulation Working Group. Manolis E, et al. Among authors: cole s. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):416-417. doi: 10.1002/psp4.12223. Epub 2017 Jul 22. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28653481 Free PMC article.
Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).
Musuamba FT, Manolis E, Holford N, Cheung S, Friberg LE, Ogungbenro K, Posch M, Yates J, Berry S, Thomas N, Corriol-Rohou S, Bornkamp B, Bretz F, Hooker AC, Van der Graaf PH, Standing JF, Hay J, Cole S, Gigante V, Karlsson K, Dumortier T, Benda N, Serone F, Das S, Brochot A, Ehmann F, Hemmings R, Rusten IS. Musuamba FT, et al. Among authors: cole s. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):418-429. doi: 10.1002/psp4.12196. Epub 2017 Jul 19. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28722322 Free PMC article.
The Importance of the Human Mass Balance Study in Regulatory Submissions.
Coppola P, Andersson A, Cole S. Coppola P, et al. Among authors: cole s. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):792-804. doi: 10.1002/psp4.12466. Epub 2019 Oct 25. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31515957 Free PMC article. Review.
3,238 results