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Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop.
Romero K, Sinha V, Allerheiligen S, Danhof M, Pinheiro J, Kruhlak N, Wang Y, Wang SJ, Sauer JM, Marier JF, Corrigan B, Rogers J, Lambers Heerspink HJ, Gumbo T, Vis P, Watkins P, Morrison T, Gillespie W, Gordon MF, Stephenson D, Hanna D, Pfister M, Lalonde R, Colatsky T. Romero K, et al. Among authors: pinheiro j. J Pharmacokinet Pharmacodyn. 2014 Dec;41(6):545-52. doi: 10.1007/s10928-014-9390-0. Epub 2014 Oct 7. J Pharmacokinet Pharmacodyn. 2014. PMID: 25288257
Comment on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharmaceutical Statistics 17 (5):593-606, Sep/Oct 2018, DOI: 10.1002/pst.1873.
Krause A, Kloft C, Huisinga W, Karlsson M, Pinheiro J, Bies R, Rogers J, Mentré F, Musser BJ; ASA Special Interest Group on Statistics and Pharmacometrics/ASA Special Interest Group on Statistics and Pharmacometrics (SIG SxP). Krause A, et al. Among authors: pinheiro j. Pharm Stat. 2019 May;18(3):278-281. doi: 10.1002/pst.1940. Epub 2019 Apr 1. Pharm Stat. 2019. PMID: 30932340 No abstract available.
Dynamic population pharmacokinetic-pharmacodynamic modelling and simulation supports similar efficacy in glycosylated haemoglobin response with once or twice-daily dosing of canagliflozin.
de Winter W, Dunne A, de Trixhe XW, Devineni D, Hsu CH, Pinheiro J, Polidori D. de Winter W, et al. Among authors: pinheiro j. Br J Clin Pharmacol. 2017 May;83(5):1072-1081. doi: 10.1111/bcp.13180. Epub 2017 Jan 31. Br J Clin Pharmacol. 2017. PMID: 28138980 Free PMC article. Clinical Trial.
714 results