Search Results - "GUTMAN, Steven I"

Medical applications of microarray technologies: a regulatory science perspective by Petricoin, 3rd, Emanuel F, Hackett, Joseph L, Lesko, Lawrence J, Puri, Raj K, Gutman, Steven I, Chumakov, Konstantin, Woodcock, Janet, Feigal, Jr, David W, Zoon, Kathryn C, Sistare, Frank D

“…The potential medical applications of microarrays have generated much excitement, and some skepticism, within the biomedical community. Some researchers have…”
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The Role of Minimal Residual Disease Testing in Myeloma Treatment Selection and Drug Development: Current Value and Future Applications by Anderson, Kenneth C, Auclair, Daniel, Kelloff, Gary J, Sigman, Caroline C, Avet-Loiseau, Hervé, Farrell, Ann T, Gormley, Nicole J, Kumar, Shaji K, Landgren, Ola, Munshi, Nikhil C, Cavo, Michele, Davies, Faith E, Di Bacco, Alessandra, Dickey, Jennifer S, Gutman, Steven I, Higley, Howard R, Hussein, Mohamad A, Jessup, J Milburn, Kirsch, Ilan R, Little, Richard F, Loberg, Robert D, Lohr, Jens G, Mukundan, Lata, Omel, James L, Pugh, Trevor J, Reaman, Gregory H, Robbins, Michael D, Sasser, A Kate, Valente, Nancy, Zamagni, Elena

“…Treatment of myeloma has benefited from the introduction of more effective and better tolerated agents, improvements in supportive care, better understanding…”
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Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer by Parkinson, David R, McCormack, Robert T, Keating, Susan M, Gutman, Steven I, Hamilton, Stanley R, Mansfield, Elizabeth A, Piper, Margaret A, Deverka, Patricia, Frueh, Felix W, Jessup, J Milburn, McShane, Lisa M, Tunis, Sean R, Sigman, Caroline C, Kelloff, Gary J

“…This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular…”
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Point-of-care biosensor systems for cancer diagnostics/prognostics by Soper, Steven A., Brown, Kathlynn, Ellington, Andrew, Frazier, Bruno, Garcia-Manero, Guillermo, Gau, Vincent, Gutman, Steven I., Hayes, Daniel F., Korte, Brenda, Landers, James L., Larson, Dale, Ligler, Frances, Majumdar, Arun, Mascini, Marco, Nolte, David, Rosenzweig, Zeev, Wang, Joseph, Wilson, David

“…With the growing number of fatalities resulting from the 100 or so cancer-related diseases, new enabling tools are required to provide extensive molecular…”
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A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment by Taube, Sheila E., Clark, Gary M., Dancey, Janet E., McShane, Lisa M., Sigman, Caroline C., Gutman, Steven I.

“…A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in…”
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FDA perspectives on potential microarray-based clinical diagnostics by Tezak, Zivana, Ranamukhaarachchi, Daya, Russek-Cohen, Estelle, Gutman, Steven I

“…The US Food and Drug Administration (FDA) encourages the development of new technologies such as microarrays which may improve and streamline assessments of…”
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Introduction to the Food and Drug Administration (FDA) Regulatory Process by Hackett, Joseph L, Gutman, Steven I

“…FDA oversight of medical devices, including in vitro diagnostic devices (IVDs or laboratory tests), in the United States was a direct result of the passage of…”
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Food and Drug Administration Regulation of in Vitro Diagnostic Devices by Mansfield, Elizabeth, O'Leary, Timothy J., Gutman, Steven I.

“…The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to…”
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Counterpoint: Food and Drug Administration guidance for C-reactive protein assays: matching claims with performance data by Callaghan, James V, Gutman, Steven I

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FDA perspectives on pharmacogenetic testing by Harper, Courtney C, Philip, Reena, Robinowitz, Max, Gutman, Steven I

“…The field of pharmacogenetic testing is emerging as a topic of interest for many, due to its potential to improve patient care and optimize therapeutic…”
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Consumers report glucose meter problems to FDA by Gutman, Steven I, Fuller, Janie G, Hausman, Ethan D

“…Glucose meters have unquestionable clinical utility, particularly in management of diabetes mellitus. U.S. Food and Drug Administration (FDA) surveillance…”
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Evidence of Clinical Utility: An Unmet Need in Molecular Diagnostics for Patients with Cancer : PRECISION MEDICINE by PARKINSON, David R, McCORMACK, Robert T, McSHANE, Lisa M, TUNIS, Sean R, SIGMAN, Caroline C, KELLOFF, Gary J, KEATING, Susan M, GUTMAN, Steven I, HAMILTON, Stanley R, MANSFIELD, Elizabeth A, PIPER, Margaret A, DEVERKA, Patricia, FRUEH, Felix W, JESSUP, J. Milburn

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Comparison of 2,3,7,8-tetrachlorodibenzo-p-dioxin-mediated hepatotoxicity in C57BL/6J and DBA/2J mice by Shen, E S, Gutman, S I, Olson, J R

“…The toxicity of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) was examined by clinical chemistry and liver histopathology in Ah-responsive C57BL/6J (C57) and…”
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The use of laboratory intervention to stem the flow of fresh-frozen plasma by Solomon, R R, Clifford, J S, Gutman, S I

“…Four methods of laboratory intervention were tested by the hospital blood bank in an effort to modify the use of fresh-frozen plasma (FFP). Over a one-year…”
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Medical applications of microarray technologies: a regulatory science perspective by PETRICOIN, Emanuel F, HACKETT, Joseph L, LESKO, Lawrence J, PURI, Raj K, GUTMAN, Steven I, CHUMAKOV, Konstantin, WOODCOCK, Janet, FEIGAL, David W, ZOON, Kathryn C, SISTARE, Frank D

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Malignant peritoneal mesothelioma in a child by Gutman, S I, Steinherz, P G, Gray, G F

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FDA Antibody Rules by Gutman, Steven I., Takes, Peter A., Graham, Delores

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A comparison between erythrocyte sedimentation rate (ESR) and selected acute-phase proteins in the elderly by Katz, P R, Karuza, J, Gutman, S I, Bartholomew, W, Richman, G

“…The erythrocyte sedimentation rate (ESR) and selected acute-phase proteins (APPs) were studied in 101 elderly people (mean age, 72 years) to determine their…”
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Methyldopa Hepatitis. A report of six cases and review of the literature by Rodman, J S, Deutsch, D J, Gutman, S I

“…Six cases of methyldopa hepatitis, including two in which the patients died are reported; and 77 cases from the literature are reviewed. Patients in whom…”
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The clinical significance of dipstick-negative, culture-positive urines in a veterans population by Gutman, S I, Solomon, R R

“…The consequences of omitting cultures in dipstick-negative urines submitted to the authors' microbiology laboratory were evaluated retrospectively in 1,079…”
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