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Items: 29

1.

The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications.

Anderson KC, Auclair D, Kelloff GJ, Sigman CC, Avet-Loiseau H, Farrell AT, Gormley NJ, Kumar SK, Landgren O, Munshi NC, Cavo M, Davies FE, Di Bacco A, Dickey JS, Gutman SI, Higley HR, Hussein MA, Jessup JM, Kirsch IR, Little RF, Loberg RD, Lohr JG, Mukundan L, Omel JL, Pugh TJ, Reaman GH, Robbins MD, Sasser AK, Valente N, Zamagni E.

Clin Cancer Res. 2017 Aug 1;23(15):3980-3993. doi: 10.1158/1078-0432.CCR-16-2895. Epub 2017 Apr 20.

2.

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.

Clin Cancer Res. 2014 Mar 15;20(6):1428-44. doi: 10.1158/1078-0432.CCR-13-2961.

3.
4.

Progression-Free Survival: What Does It Mean for Psychological Well-Being or Quality of Life? [Internet].

Gutman SI, Piper M, Grant MD, Basch E, Oliansky DM, Aronson N.

Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr.

5.

A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment.

Taube SE, Clark GM, Dancey JE, McShane LM, Sigman CC, Gutman SI.

J Natl Cancer Inst. 2009 Nov 4;101(21):1453-63. doi: 10.1093/jnci/djp334. Epub 2009 Oct 23.

6.
7.

Point-of-care biosensor systems for cancer diagnostics/prognostics.

Soper SA, Brown K, Ellington A, Frazier B, Garcia-Manero G, Gau V, Gutman SI, Hayes DF, Korte B, Landers JL, Larson D, Ligler F, Majumdar A, Mascini M, Nolte D, Rosenzweig Z, Wang J, Wilson D.

Biosens Bioelectron. 2006 Apr 15;21(10):1932-42. Epub 2006 Feb 13. Review.

PMID:
16473506
8.

FDA perspectives on potential microarray-based clinical diagnostics.

Tezak Z, Ranamukhaarachchi D, Russek-Cohen E, Gutman SI.

Hum Genomics. 2006 Jan;2(4):236-43.

9.

FDA perspectives on pharmacogenetic testing.

Harper CC, Philip R, Robinowitz M, Gutman SI.

Expert Rev Mol Diagn. 2005 Sep;5(5):643-8.

PMID:
16149867
10.

Introduction to the Food and Drug Administration (FDA) regulatory process.

Hackett JL, Gutman SI.

J Proteome Res. 2005 Jul-Aug;4(4):1110-3. Review.

PMID:
16083260
11.

Consumers report glucose meter problems to FDA.

Gutman SI, Fuller JG, Hausman ED.

Diabetes Technol Ther. 2004 Dec;6(6):767-9.

PMID:
15684627
12.

Food and Drug Administration regulation of in vitro diagnostic devices.

Mansfield E, O'Leary TJ, Gutman SI.

J Mol Diagn. 2005 Feb;7(1):2-7. Review.

13.

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.

Nat Genet. 2002 Dec;32 Suppl:474-9. Review.

PMID:
12454641
14.

FDA's new regulatory paradigms for in vitro diagnostic devices.

Robinowitz M, Gutman SI.

Cytotherapy. 1999;1(4):353-7. doi: 10.1080/0032472031000141278. No abstract available.

PMID:
20426566
15.

Regulatory issues unique to clinical trials on periodontal diagnostic methods and devices.

Gutman SI, Tylenda CA.

Ann Periodontol. 1997 Mar;2(1):108-12.

PMID:
9151547
16.

The FDA's perspective on clinical laboratory devices. The premarket review and evaluation process.

Aziz KJ, Sliva CA, Gutman SI.

Am Clin Lab. 1996 Jan-Feb;15(1):10-1. No abstract available.

PMID:
10163487
17.

FDA antibody rules.

Gutman SI.

Science. 1995 Aug 4;269(5224):619-20. No abstract available.

PMID:
7624784
18.

Simple, rapid method for determining nitrates and nitrites in biological fluids.

Gutman SI, Hollywood CA.

Clin Chem. 1992 Oct;38(10):2152. No abstract available.

PMID:
1395012
19.

Renal responses during a dry saturation dive to 450 msw.

Goldinger JM, Hong SK, Claybaugh JR, Niu AK, Gutman SI, Moon RE, Bennett PB.

Undersea Biomed Res. 1992 Jul;19(4):287-93.

PMID:
1496753
20.

Comparison of 2,3,7,8-tetrachlorodibenzo-p-dioxin-mediated hepatotoxicity in C57BL/6J and DBA/2J mice.

Shen ES, Gutman SI, Olson JR.

J Toxicol Environ Health. 1991 Apr;32(4):367-81.

PMID:
2016751
21.

A comparison between erythrocyte sedimentation rate (ESR) and selected acute-phase proteins in the elderly.

Katz PR, Karuza J, Gutman SI, Bartholomew W, Richman G.

Am J Clin Pathol. 1990 Nov;94(5):637-40.

PMID:
1700597
23.

Erythrocyte sedimentation rate and C-reactive protein compared in the elderly.

Katz PR, Gutman SI, Richman G, Karuza J, Bartholomew WR, Baum J.

Clin Chem. 1989 Mar;35(3):466-8.

24.
25.

The use of laboratory intervention to stem the flow of fresh-frozen plasma.

Solomon RR, Clifford JS, Gutman SI.

Am J Clin Pathol. 1988 Apr;89(4):518-21.

PMID:
3354505
26.

The clinical significance of dipstick-negative, culture-positive urines in a veterans population.

Gutman SI, Solomon RR.

Am J Clin Pathol. 1987 Aug;88(2):204-9.

PMID:
3618553
27.

Two new artifacts in automated coagulation testing.

Gutman SI, Didisheim P, Markowitz H.

Am J Clin Pathol. 1980 Apr;73(4):583-8.

PMID:
7369183
28.

Malignant peritoneal mesothelioma in a child.

Gutman SI, Steinherz PG, Gray GF.

Am J Dis Child. 1976 Nov;130(11):1268-9. No abstract available.

PMID:
62511
29.

Methyldopa Hepatitis. A report of six cases and review of the literature.

Rodman JS, Deutsch DJ, Gutman SI.

Am J Med. 1976 Jun;60(7):941-8.

PMID:
937354

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