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The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions

Statistical methods in medical research, 2015-02, Vol.24 (1), p.9-26

2015

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Metrology Standards for Quantitative Imaging Biomarkers

Radiology, 2015-12, Vol.277 (3), p.813-825

2015

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Quantitative imaging biomarkers: A review of statistical methods for technical performance assessment

Statistical methods in medical research, 2015-02, Vol.24 (1), p.27-67

2015

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Considerations for Single-Measurement Risk-Stratification Strategies for Myocardial Infarction Using Cardiac Troponin Assays

Journal of the American College of Cardiology, 2019-07, Vol.74 (3), p.283-284

2019

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A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays

Microbiology spectrum, 2022-02, Vol.10 (1), p.e0156421-e0156421

2022

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US FDA and personalized medicine: in vitro diagnostic regulatory perspective

Personalized medicine, 2010-09, Vol.7 (5), p.517-530

2010

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Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration

Clinical chemistry (Baltimore, Md.), 2010-02, Vol.56 (2), p.165-171

2010

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Patient Safety and the Next Generation of HPV DNA Tests

American journal of clinical pathology, 2011-05, Vol.135 (5), p.798-799

2011

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Comparing Two Medical Tests When Results of Reference Standard Are Unavailable for Those Negative via Both Tests

Journal of biopharmaceutical statistics, 2008-01, Vol.18 (1), p.145-166

Kondratovich, Marina V.

2008

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US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer

Journal of clinical oncology, 2023-04, Vol.41 (11), p.2108-2116

2023

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Abstract 56: Individual Susceptibility to Drug-induced QTc Prolongation Did Not Correlate With Subject-specific Induced Pluripotent Stem Cells in a Small Sample of Healthy Subjects

Circulation research, 2017-07, Vol.121 (suppl_1)

2017

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Statistical Design for Biospecimen Cohort Size in Proteomics-based Biomarker Discovery and Verification Studies

Journal of proteome research, 2013-12, Vol.12 (12), p.5383-5394

2013

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Partly Nonparametric Approach for Determining the Limit of Detection

Clinical chemistry (Baltimore, Md.), 2004-04, Vol.50 (4), p.732-740

2004

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LB-15. A Trans-Governmental Collaborative Effort to Independently Evaluate SARS-CoV-2 Serology Assays Using Well-Characterized Sample Panels

Open forum infectious diseases, 2020-12, Vol.7 (Supplement_1), p.S851-S851

2020

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Analytical Validation of Protein-Based Multiplex Assays: A Workshop Report by the NCI-FDA Interagency Oncology Task Force on Molecular Diagnostics

Clinical chemistry (Baltimore, Md.), 2010-02, Vol.56 (2), p.237-243

2010

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Patient Safety and the Next Generation of HPV DNA TestsThe Authors’ ReplyPostscript

American journal of clinical pathology, 2011-05, Vol.135 (5), p.798-803

2011

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Patient Safety and the Next Generation of HPV DNA Tests/The Authors' Reply

American journal of clinical pathology, 2011-05, Vol.135 (5), p.798

2011

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US FDA and personalized medicine

Personalized medicine, 2010-09, Vol.7 (5), p.517-530

2010

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Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine

Therapeutic delivery, 2010-11, Vol.1 (5), p.631-641

2010

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Central venous catheter tip placement and catheter occlusion

The American journal of surgery, 2000-07, Vol.180 (1), p.78-79

2000

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Comparison of independent and stratified sampling schemes in problems of global optimization

Monte Carlo and Quasi-Monte Carlo Methods 1996, p.292-299

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The emerging science of quantitative imaging biomarkers terminology and definitions for scientific studies and regulatory submissions

Metrology Standards for Quantitative Imaging Biomarkers

Quantitative imaging biomarkers: A review of statistical methods for technical performance assessment

Considerations for Single-Measurement Risk-Stratification Strategies for Myocardial Infarction Using Cardiac Troponin Assays

A Trans-Governmental Collaboration to Independently Evaluate SARS-CoV-2 Serology Assays

US FDA and personalized medicine: in vitro diagnostic regulatory perspective

Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration

Patient Safety and the Next Generation of HPV DNA Tests

Comparing Two Medical Tests When Results of Reference Standard Are Unavailable for Those Negative via Both Tests

US Food and Drug Administration Approval Summary: Fam-Trastuzumab Deruxtecan-nxki for Human Epidermal Growth Factor Receptor 2-Low Unresectable or Metastatic Breast Cancer

Abstract 56: Individual Susceptibility to Drug-induced QTc Prolongation Did Not Correlate With Subject-specific Induced Pluripotent Stem Cells in a Small Sample of Healthy Subjects

Statistical Design for Biospecimen Cohort Size in Proteomics-based Biomarker Discovery and Verification Studies

Partly Nonparametric Approach for Determining the Limit of Detection

LB-15. A Trans-Governmental Collaborative Effort to Independently Evaluate SARS-CoV-2 Serology Assays Using Well-Characterized Sample Panels

Analytical Validation of Protein-Based Multiplex Assays: A Workshop Report by the NCI-FDA Interagency Oncology Task Force on Molecular Diagnostics

Patient Safety and the Next Generation of HPV DNA TestsThe Authors’ ReplyPostscript

Patient Safety and the Next Generation of HPV DNA Tests/The Authors' Reply

US FDA and personalized medicine

Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine

Central venous catheter tip placement and catheter occlusion

Comparison of independent and stratified sampling schemes in problems of global optimization

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