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Complex DDI by Fenebrutinib and the Use of Transporter Endogenous Biomarkers to Elucidate the Mechanism of DDI

Clinical pharmacology and therapeutics, 2020-01, Vol.107 (1), p.269-277

2020

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Drug Concentration Asymmetry in Tissues and Plasma for Small Molecule-Related Therapeutic Modalities

Drug metabolism and disposition, 2019-10, Vol.47 (10), p.1122-1135

2019

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Drug–Drug Interaction Potential of Marketed Oncology Drugs: In Vitro Assessment of Time-Dependent Cytochrome P450 Inhibition, Reactive Metabolite Formation and Drug–Drug Interaction Prediction

Pharmaceutical research, 2012-07, Vol.29 (7), p.1960-1976

2012

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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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Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control

Drug metabolism and disposition, 2017-10, Vol.45 (10), p.1049-1059

2017

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Discovery of Potent and Selective Pyrazolopyrimidine Janus Kinase 2 Inhibitors

Journal of medicinal chemistry, 2012-11, Vol.55 (22), p.10090-10107

2012

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Does In Vitro Cytochrome P450 Downregulation Translate to In Vivo Drug‐Drug Interactions? Preclinical and Clinical Studies With 13‐cis‐Retinoic Acid

Clinical and translational science, 2019-07, Vol.12 (4), p.350-360

2019

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Comparative Assessment of In Vitro–In Vivo Extrapolation Methods used for Predicting Hepatic Metabolic Clearance of Drugs

Journal of pharmaceutical sciences, 2012-11, Vol.101 (11), p.4308-4326

2012

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Phase I and scintigraphy studies to evaluate safety, tolerability, pharmacokinetics, and lung deposition of inhaled GDC‐0214 in healthy volunteers

Clinical and translational science, 2022-05, Vol.15 (5), p.1225-1237

2022

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Automated assessment of time-dependent inhibition of human cytochrome P450 enzymes using liquid chromatography-tandem mass spectrometry analysis

Drug metabolism and disposition, 2005-11, Vol.33 (11), p.1637-1647

2005

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Chemical inhibitors of cytochrome P450 isoforms in human liver microsomes: a re-evaluation of P450 isoform selectivity

European journal of drug metabolism and pharmacokinetics, 2011-03, Vol.36 (1), p.1-16

2011

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Evaluation of multiple in vitro systems for assessment of CYP3A4 induction in drug discovery: human hepatocytes, pregnane X receptor reporter gene, and Fa2N-4 and HepaRG cells

Drug metabolism and disposition, 2009-06, Vol.37 (6), p.1259-1268

2009

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Using the Dynamic Well-Stirred Model to Extrapolate Hepatic Clearance of Organic Anion-Transporting Polypeptide Transporter Substrates without Assuming Albumin-Mediated Hepatic Drug Uptake

Drug metabolism and disposition, 2024-05, Vol.52 (6), p.548-554

2024

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Microphysiological systems for ADME-related applications: current status and recommendations for system development and characterization

Lab on a chip, 2020-02, Vol.2 (3), p.446-467

2020

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New Methodology for Determining Plasma Protein Binding Kinetics Using an Enzyme Reporter Assay Coupling with High-Resolution Mass Spectrometry

Analytical chemistry (Washington), 2023-02, Vol.95 (8), p.4086-4094

2023

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Perspectives from the Innovation and Quality Consortium Induction Working Group on Factors Impacting Clinical Drug-Drug Interactions Resulting from Induction: Focus on Cytochrome 3A Substrates

Drug metabolism and disposition, 2019-10, Vol.47 (10), p.1206-1221

2019

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Introducing the Dynamic Well-Stirred Model for Predicting Hepatic Clearance and Extraction Ratio

Journal of pharmaceutical sciences, 2024-04, Vol.113 (4), p.1094-1112

2024

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Isotretinoin and its Metabolites Alter mRNA of Multiple Enzyme and Transporter Genes In Vitro, but Downregulation of Organic Anion Transporting Polypeptide Does Not Translate to the Clinic

Drug metabolism and disposition, 2022-07, Vol.50 (7), p.1042-1052

2022

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Identification of a Discrete Diglucuronide of GDC-0810 in Human Plasma after Oral Administration

Drug metabolism and disposition, 2023-10, Vol.51 (10), p.1284-1294

2023

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Strategy for Determining the Free Fraction of Labile Covalent Modulators in Plasma Using Equilibrium Dialysis

Journal of pharmaceutical sciences, 2020-10, Vol.109 (10), p.3181-3189

2020

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Prediction of Drug-Drug Interactions Arising from CYP3A induction Using a Physiologically Based Dynamic Model

Drug metabolism and disposition, 2016-06, Vol.44 (6), p.821-832

2016

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Inhaled JAK inhibitor GDC-0214 reduces exhaled nitric oxide in patients with mild asthma: A randomized, controlled, proof-of-activity trial

Journal of allergy and clinical immunology, 2021-09, Vol.148 (3), p.783-789

2021

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Syntheses and Characterization of the Acyl Glucuronide and Hydroxy Metabolites of Diclofenac

Journal of medicinal chemistry, 2004-05, Vol.47 (11), p.2816-2825

2004

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Improving Confidence in the Determination of Free Fraction for Highly Bound Drugs Using Bidirectional Equilibrium Dialysis

Journal of pharmaceutical sciences, 2019-03, Vol.108 (3), p.1296-1302

2019

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In Vitro–In Vivo Extrapolation of Clearance: Modeling Hepatic Metabolic Clearance of Highly Bound Drugs and Comparative Assessment with Existing Calculation Methods

Journal of pharmaceutical sciences, 2012-02, Vol.101 (2), p.838-851

2012

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Complex DDI by Fenebrutinib and the Use of Transporter Endogenous Biomarkers to Elucidate the Mechanism of DDI

Drug Concentration Asymmetry in Tissues and Plasma for Small Molecule-Related Therapeutic Modalities

Drug–Drug Interaction Potential of Marketed Oncology Drugs: In Vitro Assessment of Time-Dependent Cytochrome P450 Inhibition, Reactive Metabolite Formation and Drug–Drug Interaction Prediction

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

Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control

Discovery of Potent and Selective Pyrazolopyrimidine Janus Kinase 2 Inhibitors

Does In Vitro Cytochrome P450 Downregulation Translate to In Vivo Drug‐Drug Interactions? Preclinical and Clinical Studies With 13‐cis‐Retinoic Acid

Comparative Assessment of In Vitro–In Vivo Extrapolation Methods used for Predicting Hepatic Metabolic Clearance of Drugs

Phase I and scintigraphy studies to evaluate safety, tolerability, pharmacokinetics, and lung deposition of inhaled GDC‐0214 in healthy volunteers

Automated assessment of time-dependent inhibition of human cytochrome P450 enzymes using liquid chromatography-tandem mass spectrometry analysis

Chemical inhibitors of cytochrome P450 isoforms in human liver microsomes: a re-evaluation of P450 isoform selectivity

Evaluation of multiple in vitro systems for assessment of CYP3A4 induction in drug discovery: human hepatocytes, pregnane X receptor reporter gene, and Fa2N-4 and HepaRG cells

Using the Dynamic Well-Stirred Model to Extrapolate Hepatic Clearance of Organic Anion-Transporting Polypeptide Transporter Substrates without Assuming Albumin-Mediated Hepatic Drug Uptake

Microphysiological systems for ADME-related applications: current status and recommendations for system development and characterization

New Methodology for Determining Plasma Protein Binding Kinetics Using an Enzyme Reporter Assay Coupling with High-Resolution Mass Spectrometry

Perspectives from the Innovation and Quality Consortium Induction Working Group on Factors Impacting Clinical Drug-Drug Interactions Resulting from Induction: Focus on Cytochrome 3A Substrates

Introducing the Dynamic Well-Stirred Model for Predicting Hepatic Clearance and Extraction Ratio

Isotretinoin and its Metabolites Alter mRNA of Multiple Enzyme and Transporter Genes In Vitro, but Downregulation of Organic Anion Transporting Polypeptide Does Not Translate to the Clinic

Identification of a Discrete Diglucuronide of GDC-0810 in Human Plasma after Oral Administration

Strategy for Determining the Free Fraction of Labile Covalent Modulators in Plasma Using Equilibrium Dialysis

Prediction of Drug-Drug Interactions Arising from CYP3A induction Using a Physiologically Based Dynamic Model

Inhaled JAK inhibitor GDC-0214 reduces exhaled nitric oxide in patients with mild asthma: A randomized, controlled, proof-of-activity trial

Syntheses and Characterization of the Acyl Glucuronide and Hydroxy Metabolites of Diclofenac

Improving Confidence in the Determination of Free Fraction for Highly Bound Drugs Using Bidirectional Equilibrium Dialysis

In Vitro–In Vivo Extrapolation of Clearance: Modeling Hepatic Metabolic Clearance of Highly Bound Drugs and Comparative Assessment with Existing Calculation Methods

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