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Regulation, Reimbursement, and the Long Road of Implementation of Personalized Medicine—A Perspective from the United States

Value in health, 2013-09, Vol.16 (6), p.S27-S31

Frueh, Felix W., PhD

2013

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The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies

BMC bioinformatics, 2008-08, Vol.9 Suppl 9 (Suppl 9), p.S10-S10, Article S10

2008

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Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Pharmacotherapy, 2008-08, Vol.28 (8), p.992-998

2008

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Strategic paths for biomarker qualification

Toxicology (Amsterdam), 2008-03, Vol.245 (3), p.219-223

2008

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Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential

BMC bioinformatics, 2005-07, Vol.6 Suppl 2 (S2), p.S12-S12, Article S12

2005

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On rat poison and human medicines: personalizing warfarin therapy

Trends in molecular medicine, 2012-04, Vol.18 (4), p.201-205

Frueh, Felix W

2012

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Back to the future: why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine

Pharmacogenomics, 2009-07, Vol.10 (7), p.1077-1081

Frueh, Felix W

2009

Volltextzugriff (PDF)

Impact of Proton Pump Inhibitors on the Effectiveness of Clopidogrel After Coronary Stent Placement: The Clopidogrel Medco Outcomes Study

Pharmacotherapy, 2010-08, Vol.30 (8), p.787-796

2010

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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Molecular diagnostics clinical utility strategy: a six-part framework

Expert review of molecular diagnostics, 2014-09, Vol.14 (7), p.777-786

2014

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Impact of microarray data quality on genomic data submissions to the FDA

Nature biotechnology, 2006-09, Vol.24 (9), p.1105-1107

Frueh, Felix W

2006

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Real-world clinical effectiveness, regulatory transparency and payer coverage: three ingredients for translating pharmacogenomics into clinical practice

Pharmacogenomics, 2010-05, Vol.11 (5), p.657-660

Frueh, Felix W

2010

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Considerations for safety pharmacogenetics in clinical practice

Drug discovery today, 2011-10, Vol.16 (19), p.898-901

Frueh, Felix W.

2011

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The future of direct-to-consumer clinical genetic tests

Nature reviews. Genetics, 2011-07, Vol.12 (7), p.511

2011

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Implementing the U.S. FDA guidance on pharmacogenomic data submissions

Environmental and molecular mutagenesis, 2007-06, Vol.48 (5), p.354-358

2007

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From pharmacogenetics to personalized medicine: a vital need for educating health professionals and the community

Pharmacogenomics, 2004-07, Vol.5 (5), p.571-579

2004

Volltextzugriff (PDF)

Microarray scanner calibration curves: characteristics and implications

BMC bioinformatics, 2005-07, Vol.6 Suppl 2 (S2), p.S11-S11, Article S11

2005

Volltextzugriff (PDF)

Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

Biomarkers in medicine, 2008-06, Vol.2 (3), p.305-311

2008

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Use of cDNA microarrays to analyze dioxin-induced changes in human liver gene expression

Toxicology letters, 2001-07, Vol.122 (3), p.189-203

2001

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Physician Awareness and Utilization of Food and Drug Administration (FDA)-Approved Labeling for Pharmacogenomic Testing Information

Journal of personalized medicine, 2013-06, Vol.3 (2), p.111-123

2013

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Biomarker qualification pilot process at the US Food and Drug Administration

The AAPS journal, 2007-03, Vol.9 (1), p.E105-E108

2007

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The Use of Denaturing High-Performance Liquid Chromatography (DHPLC) for the Analysis of Genetic Variations: Impact for Diagnostics and Pharmacogenetics

Clinical chemistry and laboratory medicine, 2003-04, Vol.41 (4), p.452-461

2003

Volltextzugriff (PDF)

PATIENT KNOWLEDGE OF PHARMACOGENETIC INFORMATION IMPROVES ADHERENCE TO STATIN THERAPY: RESULTS OF THE ADDITIONAL KIF6 RISK OFFERS BETTER ADHERENCE TO STATINS (AKROBATS) TRIAL

Journal of the American College of Cardiology, 2012-03, Vol.59 (13), p.E1848-E1848

2012

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QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies

Expert review of molecular diagnostics, 2004-11, Vol.4 (6), p.761-777

2004

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Payer perspectives on pharmacogenomics testing and drug development

Pharmacogenomics, 2009-01, Vol.10 (1), p.149-151

2009

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Regulation, Reimbursement, and the Long Road of Implementation of Personalized Medicine—A Perspective from the United States

The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies

Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Strategic paths for biomarker qualification

Cross-platform comparability of microarray technology: intra-platform consistency and appropriate data analysis procedures are essential

On rat poison and human medicines: personalizing warfarin therapy

Back to the future: why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine

Impact of Proton Pump Inhibitors on the Effectiveness of Clopidogrel After Coronary Stent Placement: The Clopidogrel Medco Outcomes Study

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

Molecular diagnostics clinical utility strategy: a six-part framework

Impact of microarray data quality on genomic data submissions to the FDA

Real-world clinical effectiveness, regulatory transparency and payer coverage: three ingredients for translating pharmacogenomics into clinical practice

Considerations for safety pharmacogenetics in clinical practice

The future of direct-to-consumer clinical genetic tests

Implementing the U.S. FDA guidance on pharmacogenomic data submissions

From pharmacogenetics to personalized medicine: a vital need for educating health professionals and the community

Microarray scanner calibration curves: characteristics and implications

Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective

Use of cDNA microarrays to analyze dioxin-induced changes in human liver gene expression

Physician Awareness and Utilization of Food and Drug Administration (FDA)-Approved Labeling for Pharmacogenomic Testing Information

Biomarker qualification pilot process at the US Food and Drug Administration

The Use of Denaturing High-Performance Liquid Chromatography (DHPLC) for the Analysis of Genetic Variations: Impact for Diagnostics and Pharmacogenetics

PATIENT KNOWLEDGE OF PHARMACOGENETIC INFORMATION IMPROVES ADHERENCE TO STATIN THERAPY: RESULTS OF THE ADDITIONAL KIF6 RISK OFFERS BETTER ADHERENCE TO STATINS (AKROBATS) TRIAL

QA/QC: challenges and pitfalls facing the microarray community and regulatory agencies

Payer perspectives on pharmacogenomics testing and drug development

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