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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: spear bb. Pharmacogenomics J. 2002;2(5):284-92. doi: 10.1038/sj.tpj.6500131. Pharmacogenomics J. 2002. PMID: 12439734 Review. No abstract available.
Pharmacogenomic data submissions to the FDA: clinical case studies.
Trepicchio WL, Williams GA, Essayan D, Hall ST, Harty LC, Shaw PM, Spear BB, Wang SJ, Watson ML. Trepicchio WL, et al. Among authors: spear bb. Pharmacogenomics. 2004 Jul;5(5):519-24. doi: 10.1517/14622416.5.5.519. Pharmacogenomics. 2004. PMID: 15212589 No abstract available.
Prospective-retrospective biomarker analysis for regulatory consideration: white paper from the industry pharmacogenomics working group.
Patterson SD, Cohen N, Karnoub M, Truter SL, Emison E, Khambata-Ford S, Spear B, Ibia E, Sproule R, Barnes D, Bhathena A, Bristow MR, Russell C, Wang D, Warner A, Westelinck A, Brian W, Snapir A, Franc MA, Wong P, Shaw PM. Patterson SD, et al. Pharmacogenomics. 2011 Jul;12(7):939-51. doi: 10.2217/pgs.11.52. Pharmacogenomics. 2011. PMID: 21787188
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: spear bb. J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244. J Clin Pharmacol. 2003. PMID: 12723455
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: spear bb. Pharmacogenomics. 2010 Dec;11(12):1669-75. doi: 10.2217/pgs.10.141. Pharmacogenomics. 2010. PMID: 21142909
Returning genetic research results to individuals: points-to-consider.
Renegar G, Webster CJ, Stuerzebecher S, Harty L, Ide SE, Balkite B, Rogalski-Salter TA, Cohen N, Spear BB, Barnes DM, Brazell C. Renegar G, et al. Among authors: spear bb. Bioethics. 2006 Feb;20(1):24-36. doi: 10.1111/j.1467-8519.2006.00473.x. Bioethics. 2006. PMID: 16680905 Review.
Clinical application of pharmacogenetics.
Spear BB, Heath-Chiozzi M, Huff J. Spear BB, et al. Trends Mol Med. 2001 May;7(5):201-4. doi: 10.1016/s1471-4914(01)01986-4. Trends Mol Med. 2001. PMID: 11325631
39 results