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Search for shortcuts on the critical path to market: US FDA perspectives from the diagnostic side.
Gutman S, Hackett J. Gutman S, et al. Among authors: hackett j. Pharmacogenomics. 2006 Dec;7(8):1223-7. doi: 10.2217/14622416.7.8.1223. Pharmacogenomics. 2006. PMID: 17184209
The drug diagnostic co-development concept paper: commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO Pharmacogenomics Workshop.
Hinman LM, Huang SM, Hackett J, Koch WH, Love PY, Pennello G, Torres-Cabassa A, Webster C. Hinman LM, et al. Among authors: hackett j. Pharmacogenomics J. 2006 Nov-Dec;6(6):375-80. doi: 10.1038/sj.tpj.6500392. Epub 2006 May 2. Pharmacogenomics J. 2006. PMID: 16652120 Review.
Introduction to the Food and Drug Administration (FDA) regulatory process.
Hackett JL, Gutman SI. Hackett JL, et al. J Proteome Res. 2005 Jul-Aug;4(4):1110-3. doi: 10.1021/pr050059a. J Proteome Res. 2005. PMID: 16083260 Review.
Microarray data--the US FDA, industry and academia.
Hackett JL, Lesko LJ. Hackett JL, et al. Nat Biotechnol. 2003 Jul;21(7):742-3. doi: 10.1038/nbt0703-742. Nat Biotechnol. 2003. PMID: 12833089 No abstract available.
Molecular diagnostics: an FDA perspective.
Ardekani AM, Petricoin EF 3rd, Hackett JL. Ardekani AM, et al. Expert Rev Mol Diagn. 2003 Mar;3(2):129-40. doi: 10.1586/14737159.3.2.129. Expert Rev Mol Diagn. 2003. PMID: 12647991
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: hackett j. J Clin Pharmacol. 2003 Apr;43(4):342-58. doi: 10.1177/0091270003252244. J Clin Pharmacol. 2003. PMID: 12723455
Pharmacogenomics and regulatory decision making: an international perspective.
Mendrick DL, Brazell C, Mansfield EA, Pietrusko R, Barilero I, Hackett J, St├╝rzebecher S, Jacobson-Kram D. Mendrick DL, et al. Among authors: hackett j. Pharmacogenomics J. 2006 May-Jun;6(3):154-7. doi: 10.1038/sj.tpj.6500364. Pharmacogenomics J. 2006. PMID: 16415918 No abstract available.
Medical applications of microarray technologies: a regulatory science perspective.
Petricoin EF 3rd, Hackett JL, Lesko LJ, Puri RK, Gutman SI, Chumakov K, Woodcock J, Feigal DW Jr, Zoon KC, Sistare FD. Petricoin EF 3rd, et al. Among authors: hackett jl. Nat Genet. 2002 Dec;32 Suppl:474-9. doi: 10.1038/ng1029. Nat Genet. 2002. PMID: 12454641 Review.
Quality control of microarray assays for toxicogenomic and in vitro diagnostic applications.
Thompson KL, Hackett J. Thompson KL, et al. Among authors: hackett j. Methods Mol Biol. 2008;460:45-68. doi: 10.1007/978-1-60327-048-9_3. Methods Mol Biol. 2008. PMID: 18449482 Review.
The External RNA Controls Consortium: a progress report.
Baker SC, Bauer SR, Beyer RP, Brenton JD, Bromley B, Burrill J, Causton H, Conley MP, Elespuru R, Fero M, Foy C, Fuscoe J, Gao X, Gerhold DL, Gilles P, Goodsaid F, Guo X, Hackett J, Hockett RD, Ikonomi P, Irizarry RA, Kawasaki ES, Kaysser-Kranich T, Kerr K, Kiser G, Koch WH, Lee KY, Liu C, Liu ZL, Lucas A, Manohar CF, Miyada G, Modrusan Z, Parkes H, Puri RK, Reid L, Ryder TB, Salit M, Samaha RR, Scherf U, Sendera TJ, Setterquist RA, Shi L, Shippy R, Soriano JV, Wagar EA, Warrington JA, Williams M, Wilmer F, Wilson M, Wolber PK, Wu X, Zadro R; External RNA Controls Consortium. Baker SC, et al. Among authors: hackett j. Nat Methods. 2005 Oct;2(10):731-4. doi: 10.1038/nmeth1005-731. Nat Methods. 2005. PMID: 16179916
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