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The cytochrome P450 epoxygenase pathway regulates the hepatic inflammatory response in fatty liver disease

PloS one, 2014-10, Vol.9 (10), p.e110162

2014

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Dose-finding studies in drug development for rare genetic diseases

Orphanet journal of rare diseases, 2022-04, Vol.17 (1), p.156-156, Article 156

2022

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Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs

Clinical and translational science, 2019-05, Vol.12 (3), p.236-239

2019

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Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

Nature reviews. Drug discovery, 2018-02, Vol.17 (2), p.79-80

2018

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Functional characterization of cytochrome P450-derived epoxyeicosatrienoic acids in adipogenesis and obesity

Journal of lipid research, 2014-10, Vol.55 (10), p.2124-2136

2014

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Endothelial CYP epoxygenase overexpression and soluble epoxide hydrolase disruption attenuate acute vascular inflammatory responses in mice

The FASEB journal, 2011-02, Vol.25 (2), p.703-713

2011

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Evidence, in Context: A Regulatory Perspective on Pharmacogenetics

Clinical pharmacology and therapeutics, 2022-06, Vol.111 (6), p.1202-1204

2022

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Leveraging in Vitro Models for Clinically Relevant Rare CYP2D6 Variants in Pharmacogenomics

Drug metabolism and disposition, 2024-03, Vol.52 (3), p.159-170

2024

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68Ga-Prostate-specific membrane antigen (psma) positron emission tomography (pet) in prostate cancer: a systematic review and meta-analysis

International Brazilian journal of urology, 2021-07, Vol.47 (4), p.705-729

2021

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Evaluation of Non-Invasive Methods for (R)-[ 11 C]PK11195 PET Image Quantification in Multiple Sclerosis

Journal of imaging, 2024-02, Vol.10 (2), p.39

2024

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Assessment of Dosing Strategies for Pediatric Drug Products

Clinical pharmacology and therapeutics, 2024-09, Vol.116 (3), p.716-723

2024

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A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Clinical pharmacology and therapeutics, 2021-01, Vol.109 (1), p.123-130

2021

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Trial geography, pharmacogenetics, and global drug development

Clinical pharmacology and therapeutics, 2015-03, Vol.97 (3), p.218-220

2015

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Premarket assessment of molecular alterations in drug targets: a case study of 2020 drug approvals

Pharmacogenomics, 2022-05, Vol.23 (7), p.397-404

2022

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Drivers and regulators of humoral innate immune responses to infection and cancer

Molecular immunology, 2020-05, Vol.121, p.99-110

2020

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Creating a Roadmap to Quantitative Systems Pharmacology–Informed Rare Disease Drug Development: A Workshop Report

Clinical pharmacology and therapeutics, 2024-02, Vol.115 (2), p.201-205

2024

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FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

Clinical cancer research, 2023-03, Vol.29 (5), p.838-842

2023

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Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling

The AAPS journal, 2016-05, Vol.18 (3), p.573-577

2016

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Retrospective phylogenetic analyses of formalin-fixed paraffin-embedded samples from the 2011 Rift Valley fever outbreak in South Africa, through sequencing of targeted regions

Journal of virological methods, 2021-01, Vol.287, p.114003-114003, Article 114003

2021

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Leveraging Genomic Factors to Improve Benefit–Risk

Clinical and translational science, 2017-03, Vol.10 (2), p.78-83

2017

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Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective

Circulation (New York, N.Y.), 2015-10, Vol.132 (15), p.1425-1432

2015

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Clinical Evidence Supports a Protective Role for CXCL5 in Coronary Artery Disease

The American journal of pathology, 2017-12, Vol.187 (12), p.2895-2911

2017

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Clinical and regulatory considerations in pharmacogenetic testing

American journal of health-system pharmacy, 2016-12, Vol.73 (23), p.1999-2006

2016

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Evaluation of cytochrome P450-derived eicosanoids in humans with stable atherosclerotic cardiovascular disease

Atherosclerosis, 2012-06, Vol.222 (2), p.530-536

2012

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The cytochrome P450 epoxygenase pathway regulates the hepatic inflammatory response in fatty liver disease

Dose-finding studies in drug development for rare genetic diseases

Use of Titration as a Therapeutic Individualization Strategy: An Analysis of Food and Drug Administration–Approved Drugs

Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

Functional characterization of cytochrome P450-derived epoxyeicosatrienoic acids in adipogenesis and obesity

New directions in clinical trials for frontotemporal lobar degeneration: Methods and outcome measures

Endothelial CYP epoxygenase overexpression and soluble epoxide hydrolase disruption attenuate acute vascular inflammatory responses in mice

Evidence, in Context: A Regulatory Perspective on Pharmacogenetics

Leveraging in Vitro Models for Clinically Relevant Rare CYP2D6 Variants in Pharmacogenomics

68Ga-Prostate-specific membrane antigen (psma) positron emission tomography (pet) in prostate cancer: a systematic review and meta-analysis

Evaluation of Non-Invasive Methods for (R)-[ 11 C]PK11195 PET Image Quantification in Multiple Sclerosis

Assessment of Dosing Strategies for Pediatric Drug Products

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Trial geography, pharmacogenetics, and global drug development

Premarket assessment of molecular alterations in drug targets: a case study of 2020 drug approvals

Drivers and regulators of humoral innate immune responses to infection and cancer

Creating a Roadmap to Quantitative Systems Pharmacology–Informed Rare Disease Drug Development: A Workshop Report

FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling

Retrospective phylogenetic analyses of formalin-fixed paraffin-embedded samples from the 2011 Rift Valley fever outbreak in South Africa, through sequencing of targeted regions

Leveraging Genomic Factors to Improve Benefit–Risk

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective

Clinical Evidence Supports a Protective Role for CXCL5 in Coronary Artery Disease

Clinical and regulatory considerations in pharmacogenetic testing

Evaluation of cytochrome P450-derived eicosanoids in humans with stable atherosclerotic cardiovascular disease

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