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Development and regulatory strategies for drug and diagnostic co-development.
Hinman LM, Carl KM, Spear BB, Salerno RA, Becker RL, Abbott BM, Kelly JF, Mansfield E, Katz RG, Harper C, Day SP, Pacanowski MA, Pignato W. Hinman LM, et al. Among authors: salerno ra. Pharmacogenomics. 2010 Dec;11(12):1669-75. doi: 10.2217/pgs.10.141. Pharmacogenomics. 2010. PMID: 21142909
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.
Lesko LJ, Salerno RA, Spear BB, Anderson DC, Anderson T, Brazell C, Collins J, Dorner A, Essayan D, Gomez-Mancilla B, Hackett J, Huang SM, Ide S, Killinger J, Leighton J, Mansfield E, Meyer R, Ryan SG, Schmith V, Shaw P, Sistare F, Watson M, Worobec A. Lesko LJ, et al. Among authors: salerno ra. J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244. J Clin Pharmacol. 2003. PMID: 12723455
Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group.
Anderson DC, Gomez-Mancilla B, Spear BB, Barnes DM, Cheeseman K, Shaw PM, Friedman J, McCarthy A, Brazell C, Ray SC, McHale D, Hashimoto L, Sandbrink R, Watson ML, Salerno RA, Cohen N, Lister CE; Pharmacogenetics Working Group. Anderson DC, et al. Among authors: salerno ra. Pharmacogenomics J. 2002;2(5):284-92. doi: 10.1038/sj.tpj.6500131. Pharmacogenomics J. 2002. PMID: 12439734 Review. No abstract available.
Pediatric observation units.
Conners GP, Melzer SM; Committee on Hospital Care; Committee on Pediatric Emergency Medicine; Betts JM, Chitkara MB, Jewell JA, Lye PS, Mirkinson LJ, Shaw KN, Ackerman AD, Chun TH, Conners GP, Dudley NC, Fein JA, Fuchs SM, Moore BR, Selbst SM, Wright JL. Conners GP, et al. Pediatrics. 2012 Jul;130(1):172-9. doi: 10.1542/peds.2012-1358. Epub 2012 Jun 25. Pediatrics. 2012. PMID: 22732171 Review.
41 results