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Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance

Drug metabolism and disposition, 2018-09, Vol.46 (9), p.1285-1303

2018

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The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the pharmaceutical research and manufacturers of America

Drug metabolism and disposition, 2009-07, Vol.37 (7), p.1355

2009

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In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america perspective

Drug metabolism and disposition, 2009-07, Vol.37 (7), p.1339

2009

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Disposition of asciminib, a potent BCR-ABL1 tyrosine kinase inhibitor, in healthy male subjects

Xenobiotica, 2020-02, Vol.50 (2), p.160-179

2020

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Assessment of cytochrome p450 enzyme inhibition and inactivation in drug discovery and development

Current topics in medicinal chemistry, 2011-02, Vol.11 (4), p.382

2011

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The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective

Drug metabolism and disposition, 2003-07, Vol.31 (7), p.815

2003

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MATE1 Deficiency Exacerbates Dofetilide-Induced Proarrhythmia

International journal of molecular sciences, 2022-08, Vol.23 (15), p.8607

2022

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Model‐Informed Drug Development for Everolimus Dosing Selection in Pediatric Infant Patients

CPT: pharmacometrics and systems pharmacology, 2020-04, Vol.9 (4), p.230-237

2020

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Cytochrome P450 1A2 detoxicates aristolochic acid in the mouse

Drug metabolism and disposition, 2010-05, Vol.38 (5), p.761

2010

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Practical Assessment of Clinical Drug–Drug Interactions in Drug Development Using Physiologically Based Pharmacokinetics Modeling

Clinical pharmacology and therapeutics, 2019-06, Vol.105 (6), p.1326-1328

2019

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Evaluation of Clinical Drug Interaction Potential of Clofazimine Using Static and Dynamic Modeling Approaches

Drug metabolism and disposition, 2018-01, Vol.46 (1), p.26-32

2018

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The Conduct of In Vitro and In Vivo Drug-Drug Interaction Studies: A PhRMA Perspective

Journal of clinical pharmacology, 2003-05, Vol.43 (5), p.443-469

2003

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A Physiologically-Based Pharmacokinetic Modeling Approach To Predict Drug-Drug Interactions of Sonidegib (LDE225) with Perpetrators of CYP3A in Cancer Patients

Drug metabolism and disposition, 2017-04, Vol.45 (4), p.361-374

2017

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Simultaneous Physiologically Based Pharmacokinetic (PBPK) Modeling of Parent and Active Metabolites to Investigate Complex CYP3A4 Drug-Drug Interaction Potential: A Case Example of Midostaurin

Drug metabolism and disposition, 2018-02, Vol.46 (2), p.109-121

2018

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Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions-an Industry Perspective

Drug metabolism and disposition, 2016-08, Vol.44 (8), p.1399-1423

2016

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Evaluation of the Absorption, Metabolism, and Excretion of a Single Oral 1-mg Dose of Tropifexor in Healthy Male Subjects and the Concentration Dependence of Tropifexor Metabolism

Drug metabolism and disposition, 2021-07, Vol.49 (7), p.548-562

2021

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Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Guidelines on Model Fitting and Recommendations on Time Course for In Vitro Cytochrome P450 Induction Studies Including Impact on Drug Interaction Risk Assessment

Drug metabolism and disposition, 2021-01, Vol.49 (1), p.94-110

2021

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Physiologically Based Pharmacokinetic Model Predictions of Panobinostat (LBH589) as a Victim and Perpetrator of Drug-Drug Interactions

Drug metabolism and disposition, 2017-12, Vol.45 (12), p.1304-1316

2017

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Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective

Drug metabolism and disposition, 2016-10, Vol.44 (10), p.1720-1730

2016

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Disposition and metabolism of [14C] Sacubitril/Valsartan (formerly LCZ696) an angiotensin receptor neprilysin inhibitor, in healthy subjects

Xenobiotica, 2016-11, Vol.46 (11), p.986-1000

2016

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Clinical disposition, metabolism and in vitro drug-drug interaction properties of omadacycline

Xenobiotica, 2017-08, Vol.47 (8), p.682-696

2017

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Steady-State and Pre-Steady-State Kinetic Analysis of 8-Oxo-7,8-dihydroguanosine Triphosphate Incorporation and Extension by Replicative and Repair DNA Polymerases

Biochemistry (Easton), 1998-09, Vol.37 (38), p.13300-13312

1998

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Drug Interaction Potential of Osilodrostat (LCI699) Based on Its Effect on the Pharmacokinetics of Probe Drugs of Cytochrome P450 Enzymes in Healthy Adults

Clinical drug investigation, 2017-05, Vol.37 (5), p.465-472

2017

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Evaluation of calibration curve-based approaches to predict clinical inducers and noninducers of CYP3A4 with plated human hepatocytes

Drug metabolism and disposition, 2014-09, Vol.42 (9), p.1379

2014

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Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance

The conduct of in vitro studies to address time-dependent inhibition of drug-metabolizing enzymes: a perspective of the pharmaceutical research and manufacturers of America

In vitro and in vivo induction of cytochrome p450: a survey of the current practices and recommendations: a pharmaceutical research and manufacturers of america perspective

Disposition of asciminib, a potent BCR-ABL1 tyrosine kinase inhibitor, in healthy male subjects

Assessment of cytochrome p450 enzyme inhibition and inactivation in drug discovery and development

The conduct of in vitro and in vivo drug-drug interaction studies: a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective

MATE1 Deficiency Exacerbates Dofetilide-Induced Proarrhythmia

Model‐Informed Drug Development for Everolimus Dosing Selection in Pediatric Infant Patients

Cytochrome P450 1A2 detoxicates aristolochic acid in the mouse

Practical Assessment of Clinical Drug–Drug Interactions in Drug Development Using Physiologically Based Pharmacokinetics Modeling

Evaluation of Clinical Drug Interaction Potential of Clofazimine Using Static and Dynamic Modeling Approaches

The Conduct of In Vitro and In Vivo Drug-Drug Interaction Studies: A PhRMA Perspective

A Physiologically-Based Pharmacokinetic Modeling Approach To Predict Drug-Drug Interactions of Sonidegib (LDE225) with Perpetrators of CYP3A in Cancer Patients

Simultaneous Physiologically Based Pharmacokinetic (PBPK) Modeling of Parent and Active Metabolites to Investigate Complex CYP3A4 Drug-Drug Interaction Potential: A Case Example of Midostaurin

Evaluation of a New Molecular Entity as a Victim of Metabolic Drug-Drug Interactions-an Industry Perspective

Evaluation of the Absorption, Metabolism, and Excretion of a Single Oral 1-mg Dose of Tropifexor in Healthy Male Subjects and the Concentration Dependence of Tropifexor Metabolism

Physiologically Based Pharmacokinetic Model Predictions of Panobinostat (LBH589) as a Victim and Perpetrator of Drug-Drug Interactions

Evaluation of CYP2B6 Induction and Prediction of Clinical Drug-Drug Interactions: Considerations from the IQ Consortium Induction Working Group-An Industry Perspective

Disposition and metabolism of [14C] Sacubitril/Valsartan (formerly LCZ696) an angiotensin receptor neprilysin inhibitor, in healthy subjects

Clinical disposition, metabolism and in vitro drug-drug interaction properties of omadacycline

Steady-State and Pre-Steady-State Kinetic Analysis of 8-Oxo-7,8-dihydroguanosine Triphosphate Incorporation and Extension by Replicative and Repair DNA Polymerases

Drug Interaction Potential of Osilodrostat (LCI699) Based on Its Effect on the Pharmacokinetics of Probe Drugs of Cytochrome P450 Enzymes in Healthy Adults

Evaluation of calibration curve-based approaches to predict clinical inducers and noninducers of CYP3A4 with plated human hepatocytes

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