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Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K, Catalano J, Charlab R, Close S, Cornu-Artis C, Essioux L, Fornace AJ Jr, Hinman L, Hong H, Hunt I, Jacobson-Kram D, Jawaid A, Laurie D, Lesko L, Li HH, Lindpaintner K, Mayne J, Morrow P, Papaluca-Amati M, Robison TW, Roth J, Schuppe-Koistinen I, Shi L, Spleiss O, Tong W, Truter SL, Vonderscher J, Westelinck A, Zhang L, Zineh I. Goodsaid FM, et al. Among authors: hinman l. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. doi: 10.1038/nrd3116. Nat Rev Drug Discov. 2010. PMID: 20514070 Review.
PhRMA survey of pharmacogenomic and pharmacodynamic evaluations: what next?
Grecco N, Cohen N, Warner AW, Lopez-Correa C, Truter SL, Snapir A, Piccoli SP, Wang D, Westelinck A, Hinman L, Franc MA; Industry Pharmacogenomics Working Group. Grecco N, et al. Among authors: hinman l. Clin Pharmacol Ther. 2012 Jun;91(6):1035-43. doi: 10.1038/clpt.2011.334. Clin Pharmacol Ther. 2012. PMID: 22534869
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: hinman l. 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
44 results