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Quantitative Systems Pharmacology: A Regulatory Perspective on Translation

CPT: pharmacometrics and systems pharmacology, 2019-06, Vol.8 (6), p.336-339

Zineh, Issam

2019

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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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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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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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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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High-dose atorvastatin causes a rapid sustained increase in human serum PCSK9 and disrupts its correlation with LDL cholesterol

Journal of lipid research, 2010-09, Vol.51 (9), p.2714-2721

2010

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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

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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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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

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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

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How debunking biases in research and development decisions could lead to more equitable healthcare?

Clinical and translational science, 2024-07, Vol.17 (7), p.e13880-n/a

2024

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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

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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

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US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

CPT: pharmacometrics and systems pharmacology, 2023-11, Vol.12 (11), p.1573-1576

2023

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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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Precision Dosing: A Clinical and Public Health Imperative

JAMA : the journal of the American Medical Association, 2021-04, Vol.325 (15), p.1505

2021

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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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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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Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

CPT: pharmacometrics and systems pharmacology, 2021-11, Vol.10 (11), p.1271-1275

2021

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What's Past Is Prologue: Clinical Pharmacology at the Intersection of Science, Policy, and Patients

Clinical pharmacology and therapeutics, 2020-01, Vol.107 (1), p.33-36

2020

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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

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Regulatory science – Evolution of a discipline

Drug metabolism and pharmacokinetics, 2018-01, Vol.33 (1), p.S5-S5

Zineh, Issam

2018

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The Baltimore Symphony Orchestra Performs Prokofiev's Romeo & Juliet

Pleiades (Warrensburg, Mo.), 2021, Vol.41 (2), p.120-121

Zineh, Issam

2021

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Quantitative Systems Pharmacology: A Regulatory Perspective on Translation

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

Pharmacogenetics and Coumarin Dosing — Recalibrating Expectations

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

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

High-dose atorvastatin causes a rapid sustained increase in human serum PCSK9 and disrupts its correlation with LDL cholesterol

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

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

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

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

How debunking biases in research and development decisions could lead to more equitable healthcare?

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

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

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

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

Precision Dosing: A Clinical and Public Health Imperative

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

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

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

What's Past Is Prologue: Clinical Pharmacology at the Intersection of Science, Policy, and Patients

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

Regulatory science – Evolution of a discipline

The Baltimore Symphony Orchestra Performs Prokofiev's Romeo & Juliet

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