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The value, qualification, and regulatory use of surrogate end points in drug development.
Lathia CD, Amakye D, Dai W, Girman C, Madani S, Mayne J, MacCarthy P, Pertel P, Seman L, Stoch A, Tarantino P, Webster C, Williams S, Wagner JA. Lathia CD, et al. Among authors: girman c. Clin Pharmacol Ther. 2009 Jul;86(1):32-43. doi: 10.1038/clpt.2009.69. Epub 2009 May 27. Clin Pharmacol Ther. 2009. PMID: 19474783 Review.
A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
Altar CA, Amakye D, Bounos D, Bloom J, Clack G, Dean R, Devanarayan V, Fu D, Furlong S, Hinman L, Girman C, Lathia C, Lesko L, Madani S, Mayne J, Meyer J, Raunig D, Sager P, Williams SA, Wong P, Zerba K. Altar CA, et al. Among authors: girman c. Clin Pharmacol Ther. 2008 Feb;83(2):368-71. doi: 10.1038/sj.clpt.6100451. Epub 2007 Dec 19. Clin Pharmacol Ther. 2008. PMID: 18091762
Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG).
Yuan H, Ali MS, Brouwer ES, Girman CJ, Guo JJ, Lund JL, Patorno E, Slaughter JL, Wen X, Bennett D; ISPE Comparative Effectiveness Research Special Interest Group. Yuan H, et al. Clin Pharmacol Ther. 2018 Aug;104(2):239-241. doi: 10.1002/cpt.1086. Epub 2018 May 7. Clin Pharmacol Ther. 2018. PMID: 29733448
Masking in Pragmatic Trials: Who, What, and When to Blind.
Christian JB, Brouwer ES, Girman CJ, Bennett D, Davis KJ, Dreyer NA. Christian JB, et al. Ther Innov Regul Sci. 2020 Mar;54(2):431-436. doi: 10.1007/s43441-019-00073-7. Epub 2020 Jan 8. Ther Innov Regul Sci. 2020. PMID: 32072597
214 results