Steven Gutman
Overview
Explore the profile of Steven Gutman including associated specialties, affiliations and a list of published articles.
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Articles
10
Citations
141
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0
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Recent Articles
1.
Biomarkers for pharmacogenetic and pharmacogenomic studies: special issues in analytical performance
Mansfield E, Tezak Z, Altaie S, Simon K, Gutman S
Drug Discov Today Technol
. 2014 Jul;
4(1):21-4.
PMID: 24980717
The use of in vitro tests to detect and measure biomarkers will be central to the realization of personalized medicine. The importance of proper biomarker test development processes cannot be...
2.
Mansfield E, Tezak Z, Altaie S, Simon K, Gutman S
Drug Discov Today Technol
. 2014 Jul;
4(1):17-20.
PMID: 24980716
The use of in vitro tests to detect and measure biomarkers provides promising avenues for development of new and better drugs, and will be central to the realization of personalized...
3.
Bradley L, Palomaki G, Gutman S, Samson D, Aronson N
J Urol
. 2013 Apr;
190(2):389-98.
PMID: 23545099
Purpose: We compared the effectiveness of PCA3 (prostate cancer antigen 3) and select comparators for improving initial or repeat biopsy decision making in men at risk for prostate cancer, or...
4.
Gutman S, Hackett J
Pharmacogenomics
. 2006 Dec;
7(8):1223-7.
PMID: 17184209
The US FDA has been regulating medical devices (including laboratory tests) since 1976. Premarket review is well defined and may include requirements for both analytical and clinical information. In 2004,...
5.
Gutman S, Kessler L
Nat Rev Cancer
. 2006 Jun;
6(7):565-71.
PMID: 16794639
Despite the intense interest in biomarker development for cancer management, few biomarker assays for diagnostic uses have been submitted to the US Food and Drug Administration (FDA). What challenges must...
6.
Bast Jr R, Lilja H, Urban N, Rimm D, Fritsche H, Gray J, et al.
Clin Cancer Res
. 2005 Sep;
11(17):6103-8.
PMID: 16144908
A group of investigators met at a Specialized Programs of Research Excellence Workshop to discuss key issues in the translation of biomarker discovery to the development of useful laboratory tests...
7.
8.
Hammond M, Barker P, Taube S, Gutman S
Appl Immunohistochem Mol Morphol
. 2003 Jun;
11(2):103-6.
PMID: 12777990
A workshop was sponsored by the National Institute of Standards and Technology, the Cancer Diagnosis Program of the National Cancer Institute, the Food and Drug Administration, and the College of...
9.
Gutman S, Meyer D
Arch Pathol Lab Med
. 2003 Apr;
127(5):625-6.
PMID: 12708913
No abstract available.
10.
Gutman S
Semin Oncol
. 2002 Jun;
29(3):294-300.
PMID: 12063683
The Food and Drug Administration (FDA) has been actively involved in oversight of medical devices, including in vitro diagnostic devices (IVDs) since the passage of the Medical Device Amendments of...