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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: mayne j. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. doi: 10.1038/nrd3116. Nat Rev Drug Discov. 2010. PMID: 20514070 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: mayne j. 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
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: mayne j. 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.
Global mortality of chronic liver diseases attributable to Hepatitis B virus and Hepatitis C virus infections from 1990 to 2019 and projections to 2030.
Ou TY, Huy LD, Mayne J, Shih CL, Mai Xuan H, Thi Hong Nguyen N, Nguyen Hoai L, Thi My Bui L, Chang YM, Abdi AA, Hsu SC, Lin HJ, Huang CC. Ou TY, et al. Among authors: mayne j. J Infect Public Health. 2024 Jul;17(7):102443. doi: 10.1016/j.jiph.2024.04.027. Epub 2024 May 8. J Infect Public Health. 2024. PMID: 38838606 Free article.
156 results