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Meta-analysis of microarray data using a pathway-based approach identifies a 37-gene expression signature for systemic lupus erythematosus in human peripheral blood mononuclear cells

BMC medicine, 2011-05, Vol.9 (1), p.65-65, Article 65

2011

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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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Building a roadmap to biomarker qualification: challenges and opportunities

Biomarkers in medicine, 2015-11, Vol.9 (11), p.1095-1105

2015

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Sex differences and genomics in autoimmune diseases

Journal of autoimmunity, 2012-05, Vol.38 (2), p.J254-J265

2012

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FDA Experience With Regulation of Naloxone Products to Address the Opioid Crisis and Opportunities for Leveraging Scientific Engagement

Clinical pharmacology and therapeutics, 2021-03, Vol.109 (3), p.569-572

2021

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The FDA in the 21st Century

JACC. Heart failure, 2017, Vol.5 (1), p.67-70

2017

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Evaluating the Use of KIM‐1 in Drug Development and Research Following FDA Qualification

Clinical pharmacology and therapeutics, 2018-12, Vol.104 (6), p.1175-1181

2018

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New genetic discoveries and treatment for hepatitis C

JAMA : the journal of the American Medical Association, 2012-05, Vol.307 (18), p.1921

2012

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Current Status and Future Opportunities in Lung Precision Medicine Research with a Focus on Biomarkers. An American Thoracic Society/National Heart, Lung, and Blood Institute Research Statement

American journal of respiratory and critical care medicine, 2018-12, Vol.198 (12), p.e116-e136

2018

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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Bioanalysis, 2019-12, Vol.11 (24), p.2207-2244

2019

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Translational Safety Biomarkers of Kidney Injury

Seminars in nephrology, 2019-03, Vol.39 (2), p.202-214

2019

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Hepatitis C pharmacogenetics: State of the art in 2010

Hepatology (Baltimore, Md.), 2011-01, Vol.53 (1), p.336-345

2011

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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

Bioanalysis, 2018-12, Vol.10 (24), p.1973-2001

2018

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2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays)

Bioanalysis, 2017-12, Vol.9 (24), p.1967-1996

2017

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Sex differences and genomics in autoimmune diseases: Gender, Sex Hormones, Pregnancy and Autoimmunity

Journal of autoimmunity, 2012, Vol.38 (2-3)

2012

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Biomarkers for the Development of New Medications for Cocaine Dependence

Neuropsychopharmacology (New York, N.Y.), 2014-01, Vol.39 (1), p.202-219

2014

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2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs

Bioanalysis, 2019-12, Vol.11 (23), p.2099-2132

2019

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)

Bioanalysis, 2018-12, Vol.10 (23), p.1897-1917

2018

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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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2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)

Bioanalysis, 2017-12, Vol.9 (23), p.1895-1912

2017

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Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

Nature reviews. Drug discovery, 2010-06, Vol.9 (6), p.435-445

2010

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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs)

Bioanalysis, 2017-12, Vol.9 (23), p.1895-1912

2017

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Update on the clinical pharmacogenomics of organ transplantation

Pharmacogenomics, 2010-02, Vol.11 (2), p.227-236

2010

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Response‐guided telaprevir therapy in prior relapsers? The role of bridging data from treatment‐naïve and experienced subjects

Hepatology (Baltimore, Md.), 2013-03, Vol.57 (3), p.897-902

2013

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Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects

Hepatology (Baltimore, Md.), 2013-03, Vol.57 (3), p.903-907

2013

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Meta-analysis of microarray data using a pathway-based approach identifies a 37-gene expression signature for systemic lupus erythematosus in human peripheral blood mononuclear cells

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

Building a roadmap to biomarker qualification: challenges and opportunities

Sex differences and genomics in autoimmune diseases

FDA Experience With Regulation of Naloxone Products to Address the Opioid Crisis and Opportunities for Leveraging Scientific Engagement

The FDA in the 21st Century

Evaluating the Use of KIM‐1 in Drug Development and Research Following FDA Qualification

New genetic discoveries and treatment for hepatitis C

Current Status and Future Opportunities in Lung Precision Medicine Research with a Focus on Biomarkers. An American Thoracic Society/National Heart, Lung, and Blood Institute Research Statement

Translational Safety Biomarkers of Kidney Injury

Hepatitis C pharmacogenetics: State of the art in 2010

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

2017 White Paper on recent issues in bioanalysis: a global perspective on immunogenicity guidelines & biomarker assay performance (Part 3 - LBA: immunogenicity, biomarkers and PK assays)

Sex differences and genomics in autoimmune diseases: Gender, Sex Hormones, Pregnancy and Autoimmunity

Biomarkers for the Development of New Medications for Cocaine Dependence

2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs

2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity)

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

2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)

Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact

2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs)

Update on the clinical pharmacogenomics of organ transplantation

Response‐guided telaprevir therapy in prior relapsers? The role of bridging data from treatment‐naïve and experienced subjects

Boceprevir dosing for late responders and null responders: The role of bridging data between treatment‐naïve and ‐experienced subjects

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