Gutman S - Search Results

1

Experience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.

Frueh FW, Rudman A, Simon K, Gutman S, Reed C, Dorner AJ. Frueh FW, et al. Among authors: gutman s. Pharmacogenomics J. 2006 Sep-Oct;6(5):296-300. doi: 10.1038/sj.tpj.6500380. Epub 2006 Mar 28. Pharmacogenomics J. 2006. PMID: 16568150 No abstract available.

2

Biomarkers for pharmacogenetic and pharmacogenomic studies: Locking down analytical performance.

Mansfield E, Tezak Z, Altaie S, Simon K, Gutman S. Mansfield E, et al. Among authors: gutman s. Drug Discov Today Technol. 2007 Autumn;4(1):17-20. doi: 10.1016/j.ddtec.2007.10.002. Drug Discov Today Technol. 2007. PMID: 24980716

3

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

Parkinson DR, McCormack RT, Keating SM, Gutman SI, Hamilton SR, Mansfield EA, Piper MA, Deverka P, Frueh FW, Jessup JM, McShane LM, Tunis SR, Sigman CC, Kelloff GJ. Parkinson DR, et al. Clin Cancer Res. 2014 Mar 15;20(6):1428-44. doi: 10.1158/1078-0432.CCR-13-2961. Clin Cancer Res. 2014. PMID: 24634466

4

Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance.

Mansfield E, Tezak Z, Altaie S, Simon K, Gutman S. Mansfield E, et al. Among authors: gutman s. Drug Discov Today Technol. 2007 Autumn;4(1):21-4. doi: 10.1016/j.ddtec.2007.10.001. Drug Discov Today Technol. 2007. PMID: 24980717

5

Search for shortcuts on the critical path to market: US FDA perspectives from the diagnostic side.

Gutman S, Hackett J. Gutman S, et al. Pharmacogenomics. 2006 Dec;7(8):1223-7. doi: 10.2217/14622416.7.8.1223. Pharmacogenomics. 2006. PMID: 17184209

6

FDA perspectives on pharmacogenetic testing.

Harper CC, Philip R, Robinowitz M, Gutman SI. Harper CC, et al. Expert Rev Mol Diagn. 2005 Sep;5(5):643-8. doi: 10.1586/14737159.5.5.643. Expert Rev Mol Diagn. 2005. PMID: 16149867

7

Update on FDA regulation of in vitro diagnostic devices.

Gutman S, Richter K, Alpert S. Gutman S, et al. JAMA. 1998 Jul 8;280(2):190-2. doi: 10.1001/jama.280.2.190. JAMA. 1998. PMID: 9669798 No abstract available.

8

Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with 'what-ifs'.

Surh LC, Lesko LJ, Hobbs S, Gutman S, Minasian LM, Della Pasqua OE, Austin MJ, Lu K. Surh LC, et al. Among authors: gutman s. Pharmacogenomics. 2009 Jan;10(1):137-47. doi: 10.2217/14622416.10.1.137. Pharmacogenomics. 2009. PMID: 19102723

9

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.

10

Food and Drug Administration regulation of in vitro diagnostic devices.

Mansfield E, O'Leary TJ, Gutman SI. Mansfield E, et al. J Mol Diagn. 2005 Feb;7(1):2-7. doi: 10.1016/S1525-1578(10)60002-5. J Mol Diagn. 2005. PMID: 15681468 Free PMC article. Review.

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