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

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

2010

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Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

Journal of pharmaceutical sciences, 2019-01, Vol.108 (1), p.21-25

2019

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Mechanistic Model‐Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study

Clinical pharmacology and therapeutics, 2018-01, Vol.103 (1), p.54-66

2018

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Pharmacogenomics of antihypertensive drugs: Rationale and design of the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) study

The American heart journal, 2009-03, Vol.157 (3), p.442-449

2009

Volltextzugriff (PDF)

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

CPT: pharmacometrics and systems pharmacology, 2020-01, Vol.9 (1), p.21-28

2020

Volltextzugriff (PDF)

Clinical Drug–Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access

Journal of pharmaceutical sciences, 2017-09, Vol.106 (9), p.2214-2218

2017

Volltextzugriff (PDF)

Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug‐Drug Interaction Risks

Clinical pharmacology and therapeutics, 2021-01, Vol.109 (1), p.42-46

2021

Volltextzugriff (PDF)

Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges

Nature reviews. Drug discovery, 2007-11, Vol.6 (11), p.904-916

2007

Volltextzugriff (PDF)

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

Volltextzugriff (PDF)

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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Pharmacogenomics in the Assessment of Therapeutic Risks versus Benefits: Inside the United States Food and Drug Administration

Pharmacotherapy, 2011-08, Vol.31 (8), p.729-735

2011

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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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Relationship between plasma resistin concentrations, inflammatory chemokines, and components of the metabolic syndrome in adults

Metabolism, clinical and experimental, 2008-04, Vol.57 (4), p.494-501

2008

Volltextzugriff (PDF)

Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine

Biomarkers in medicine, 2011-12, Vol.5 (6), p.705-713

2011

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The ICD Shock and Stress Management Program: A Randomized Trial of Psychosocial Treatment to Optimize Quality of Life in ICD Patients

Pacing and clinical electrophysiology, 2007-07, Vol.30 (7), p.858-864

2007

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Renin–angiotensin–aldosterone system (RAAS) pharmacogenomics: implications in heart failure management

Heart failure reviews, 2010-05, Vol.15 (3), p.209-217

2010

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Discordance between availability of pharmacogenetics studies and pharmacogenetics-based prescribing information for the top 200 drugs

The Annals of pharmacotherapy, 2006-04, Vol.40 (4), p.639

2006

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Adrenergic gene polymorphisms and cardiovascular risk in the NHLBI-sponsored Women's Ischemia Syndrome Evaluation

Journal of translational medicine, 2008-03, Vol.6 (1), p.11-11, Article 11

2008

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

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

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

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

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

Mechanistic Model‐Informed Proarrhythmic Risk Assessment of Drugs: Review of the “CiPA” Initiative and Design of a Prospective Clinical Validation Study

Pharmacogenomics of antihypertensive drugs: Rationale and design of the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) study

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

Clinical Drug–Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access

Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug‐Drug Interaction Risks

Identifying genetic risk factors for serious adverse drug reactions: current progress and challenges

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

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

Pharmacogenomics in the Assessment of Therapeutic Risks versus Benefits: Inside the United States Food and Drug Administration

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

Relationship between plasma resistin concentrations, inflammatory chemokines, and components of the metabolic syndrome in adults

Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine

The ICD Shock and Stress Management Program: A Randomized Trial of Psychosocial Treatment to Optimize Quality of Life in ICD Patients

Renin–angiotensin–aldosterone system (RAAS) pharmacogenomics: implications in heart failure management

Discordance between availability of pharmacogenetics studies and pharmacogenetics-based prescribing information for the top 200 drugs

Adrenergic gene polymorphisms and cardiovascular risk in the NHLBI-sponsored Women's Ischemia Syndrome Evaluation

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