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Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

Clinical pharmacology and therapeutics, 2015-07, Vol.98 (1), p.34-46

2015

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Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation

Clinical pharmacology and therapeutics, 2013-06, Vol.93 (6), p.515-525

2013

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What Is Clinical Utility and Why Should We Care?

Clinical pharmacology and therapeutics, 2010-12, Vol.88 (6), p.729-733

2010

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Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

Clinical pharmacology and therapeutics, 2014-05, Vol.95 (5), p.478-480

2014

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Toward Greater Insights on Pharmacokinetics and Exposure–Response Relationships for Therapeutic Biologics in Oncology Drug Development

Clinical pharmacology and therapeutics, 2017-05, Vol.101 (5), p.582-584

2017

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Next-Generation Medicines: Past Regulatory Experience and Considerations for the Future

Clinical pharmacology and therapeutics, 2014-03, Vol.95 (3), p.247-249

2014

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Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5

Clinical pharmacology and therapeutics, 2016-07, Vol.100 (1), p.75-87

2016

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Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development

The AAPS journal, 2019-11, Vol.21 (6), p.105-105, Article 105

2019

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PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of Drugs That Undergo Multiple Clearance Pathways

Clinical pharmacology and therapeutics, 2014-05, Vol.95 (5), p.550-557

2014

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The Pharmacogenetics Research Network: From SNP Discovery to Clinical Drug Response

Clinical pharmacology and therapeutics, 2007-03, Vol.81 (3), p.328-345

2007

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Cytochrome P4502D6 ( ) Gene Locus Heterogeneity: Characterization of Gene Duplication Events

Clinical pharmacology and therapeutics, 2007-02, Vol.81 (2), p.242-251

2007

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Office of Clinical Pharmacology Science Day: A Forum to Stimulate Innovation in Clinical Pharmacology

Clinical pharmacology and therapeutics, 2013-06, Vol.93 (6), p.471-473

2013

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Pharmacogenetics and Coumarin Dosing — Recalibrating Expectations

The New England journal of medicine, 2013-12, Vol.369 (24), p.2273-2275

2013

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The Utility of Modeling and Simulation in Drug Development and Regulatory Review

Journal of pharmaceutical sciences, 2013-09, Vol.102 (9), p.2912-2923

2013

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Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs

The pharmacogenomics journal, 2004-12, Vol.4 (6), p.354-358

2004

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Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

Nature reviews. Drug discovery, 2013-02, Vol.12 (2), p.103-115

2013

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Transporters in Drug Development: Scientific and Regulatory Considerations

Clinical pharmacology and therapeutics, 2018-11, Vol.104 (5), p.793-796

2018

Volltextzugriff (PDF)

Influence of phenotype and pharmacokinetics on beta-blocker drug target pharmacogenetics

The pharmacogenomics journal, 2006-05, Vol.6 (3), p.174-178

2006

Volltextzugriff (PDF)

DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA

Pharmacogenomics, 2010-04, Vol.11 (4), p.507-512

2010

Volltextzugriff (PDF)

Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective

JACC. Basic to translational science, 2018-08, Vol.3 (4), p.545-549

2018

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Angiotensin system polymorphisms and traditional risk factors as predictors of heart failure prognosis

Clinical pharmacology and therapeutics, 2005-02, Vol.77 (2), p.P63-P63

2005

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Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

The journal of clinical psychiatry, 2011-09, Vol.72 (9), p.1166

2011

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Doxycycline alters the expression of inflammatory and immune-related cytokines and chemokines in human endometrial cells: implications in irregular uterine bleeding

Human reproduction (Oxford), 2015-01, Vol.30 (1), p.249-249

2015

Volltextzugriff (PDF)

PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of DrugsThat Undergo Multiple Clearance Pathways

Clinical pharmacology and therapeutics, 2014, Vol.95 (5), p.550-557

2014

Volltextzugriff (PDF)

Early targeted drug development: Pilot FDA review of PI3K inhibitor phase I studies using a knowledge management database

Journal of clinical oncology, 2011-05, Vol.29 (15_suppl), p.3060-3060

2011

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Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation

What Is Clinical Utility and Why Should We Care?

Physiologically Based Pharmacokinetic Modeling: From Regulatory Science to Regulatory Policy

Toward Greater Insights on Pharmacokinetics and Exposure–Response Relationships for Therapeutic Biologics in Oncology Drug Development

Next-Generation Medicines: Past Regulatory Experience and Considerations for the Future

Systematic and quantitative assessment of the effect of chronic kidney disease on CYP2D6 and CYP3A4/5

Retrospective Analysis of Bioanalytical Method Validation Approaches in Biosimilar Biological Product Development

PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of Drugs That Undergo Multiple Clearance Pathways

The Pharmacogenetics Research Network: From SNP Discovery to Clinical Drug Response

Cytochrome P4502D6 ( ) Gene Locus Heterogeneity: Characterization of Gene Duplication Events

Office of Clinical Pharmacology Science Day: A Forum to Stimulate Innovation in Clinical Pharmacology

Pharmacogenetics and Coumarin Dosing — Recalibrating Expectations

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs

Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

Transporters in Drug Development: Scientific and Regulatory Considerations

Influence of phenotype and pharmacokinetics on beta-blocker drug target pharmacogenetics

DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA

Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective

Angiotensin system polymorphisms and traditional risk factors as predictors of heart failure prognosis

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

Doxycycline alters the expression of inflammatory and immune-related cytokines and chemokines in human endometrial cells: implications in irregular uterine bleeding

PBPK Model Describes the Effects of Comedication and Genetic Polymorphism on Systemic Exposure of DrugsThat Undergo Multiple Clearance Pathways

Early targeted drug development: Pilot FDA review of PI3K inhibitor phase I studies using a knowledge management database

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