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Medical applications of microarray technologies: a regulatory science perspective

Nature genetics, 2002-12, Vol.32 Suppl (4s), p.474-479

2002

Volltextzugriff (PDF)

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

Clinical cancer research, 2014-03, Vol.20 (6), p.1428-1444

2014

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

Biosensors & bioelectronics, 2006-04, Vol.21 (10), p.1932-1942

2006

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A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment

JNCI : Journal of the National Cancer Institute, 2009-11, Vol.101 (21), p.1453-1463

2009

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FDA perspectives on potential microarray-based clinical diagnostics

Human genomics, 2006-01, Vol.2 (4), p.236-243

2006

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Introduction to the Food and Drug Administration (FDA) Regulatory Process

Journal of proteome research, 2005-07, Vol.4 (4), p.1110-1113

2005

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Food and Drug Administration Regulation of in Vitro Diagnostic Devices

The Journal of molecular diagnostics : JMD, 2005-02, Vol.7 (1), p.2-7

2005

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Counterpoint: Food and Drug Administration guidance for C-reactive protein assays: matching claims with performance data

Clinical chemistry (Baltimore, Md.), 2006-07, Vol.52 (7), p.1256-1257

2006

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FDA perspectives on pharmacogenetic testing

Expert review of molecular diagnostics, 2005-09, Vol.5 (5), p.643-648

2005

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Consumers report glucose meter problems to FDA

Diabetes technology & therapeutics, 2004-12, Vol.6 (6), p.767-769

2004

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AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development

Clinical cancer research, 2010-07, Vol.16 (13), p.3299-3318

2010

Volltextzugriff (PDF)

Evidence of Clinical Utility: An Unmet Need in Molecular Diagnostics for Patients with Cancer : PRECISION MEDICINE

Clinical cancer research, 2014, Vol.20 (6), p.1428-1444

2014

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

American journal of clinical pathology, 1988-04, Vol.89 (4), p.518-521

1988

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

Journal of toxicology and environmental health, 1991-04, Vol.32 (4), p.367-381

1991

Volltextzugriff (PDF)

Medical applications of microarray technologies: a regulatory science perspective

Nature genetics, 2002, Vol.32 (DEC), p.474-479

2002

Volltextzugriff (PDF)

FDA Antibody Rules

Science (American Association for the Advancement of Science), 1995-08, Vol.269 (5224), p.619-620

1995

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Malignant peritoneal mesothelioma in a child

American journal of diseases of children (1960), 1976-11, Vol.130 (11), p.1268

1976

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

American journal of clinical pathology, 1990-11, Vol.94 (5), p.637-640

1990

Volltextzugriff (PDF)

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

American journal of clinical pathology, 1987-08, Vol.88 (2), p.204-209

1987

Volltextzugriff (PDF)

Drug Development, Regulation, and Genetically Guided Therapy

Pharmacogenomics, 2003, p.99-108

2003

Volltextzugriff (PDF)

Reexamination of the dose-response relationship for induction of the hepatic monooxygenase system by 2,3,7,8-TCDD

Chemosphere (Oxford), 1989, Vol.18 (1), p.363-370

1989

Volltextzugriff (PDF)

Methyldopa hepatitis: A report of six cases and review of the literature

The American journal of medicine, 1976-06, Vol.60 (7), p.941-948

1976

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Methyldopa hepatitis

The American journal of medicine, 1976-06, Vol.60 (7), p.941-948

1976

Volltextzugriff (PDF)

Regulatory Issues Unique to Clinical Trials on Periodontal Diagnostic Methods and Devices

Annals of periodontology, 1997-03, Vol.2 (1), p.108-112

1997

Volltextzugriff (PDF)

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Medical applications of microarray technologies: a regulatory science perspective

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

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

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

A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment

FDA perspectives on potential microarray-based clinical diagnostics

Introduction to the Food and Drug Administration (FDA) Regulatory Process

Food and Drug Administration Regulation of in Vitro Diagnostic Devices

Counterpoint: Food and Drug Administration guidance for C-reactive protein assays: matching claims with performance data

FDA perspectives on pharmacogenetic testing

Consumers report glucose meter problems to FDA

AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development

Evidence of Clinical Utility: An Unmet Need in Molecular Diagnostics for Patients with Cancer : PRECISION MEDICINE

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

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

Medical applications of microarray technologies: a regulatory science perspective

FDA Antibody Rules

Malignant peritoneal mesothelioma in a child

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

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

Drug Development, Regulation, and Genetically Guided Therapy

Reexamination of the dose-response relationship for induction of the hepatic monooxygenase system by 2,3,7,8-TCDD

Methyldopa hepatitis: A report of six cases and review of the literature

Methyldopa hepatitis

Regulatory Issues Unique to Clinical Trials on Periodontal Diagnostic Methods and Devices

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