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Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction

Clinical pharmacology and therapeutics, 2022-03, Vol.111 (3), p.624-634

2022

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Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA

Diabetologia, 2023-03, Vol.66 (3), p.603-604

2023

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Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic

Clinical pharmacology and therapeutics, 2022-03, Vol.111 (3), p.572-578

2022

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Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices

The AAPS journal, 2019-07, Vol.21 (4), p.72-72, Article 72

2019

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Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective

Journal of clinical pharmacology, 2023-11, Vol.63 (S2), p.S65-S77

2023

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Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Drug metabolism and disposition, 2016-07, Vol.44 (7), p.924-933

2016

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Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

CPT: pharmacometrics and systems pharmacology, 2021-12, Vol.10 (12), p.1479-1484

2021

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Reply to White et al

Clinical infectious diseases, 2022-08, Vol.75 (2), p.359-359

2022

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Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria

Clinical infectious diseases, 2021-09, Vol.73 (5), p.903-906

2021

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FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

The AAPS journal, 2021-04, Vol.23 (3), p.60-60, Article 60

2021

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Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions: A Review of 198 Submissions Between 2000 and 2008

Clinical pharmacokinetics, 2011-10, Vol.50 (10), p.627-635

2011

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A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development

CPT: pharmacometrics and systems pharmacology, 2020-12, Vol.9 (12), p.675-677

2020

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The Utility of a Population Approach in Drug–Drug Interaction Assessments: A Simulation Evaluation

Journal of clinical pharmacology, 2017-10, Vol.57 (10), p.1268-1278

2017

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Modeling corticosteroid effects in a rat model of rheumatoid arthritis I: mechanistic disease progression model for the time course of collagen-induced arthritis in Lewis rats

The Journal of pharmacology and experimental therapeutics, 2008-08, Vol.326 (2), p.532-545

2008

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Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response

Journal of pediatric gastroenterology and nutrition, 2017-09, Vol.65 (3), p.272-277

2017

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Utility of population pharmacokinetic modeling in the assessment of therapeutic protein-drug interactions

Journal of clinical pharmacology, 2014-05, Vol.54 (5), p.593-601

2014

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Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

The AAPS journal, 2013-10, Vol.15 (4), p.933-940

2013

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Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations

CPT: pharmacometrics and systems pharmacology, 2021-09, Vol.10 (9), p.973-982

2021

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Modeling corticosteroid effects in a rat model of rheumatoid arthritis II: mechanistic pharmacodynamic model for dexamethasone effects in Lewis rats with collagen-induced arthritis

The Journal of pharmacology and experimental therapeutics, 2008-08, Vol.326 (2), p.546-554

2008

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Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group

Journal of pharmacokinetics and pharmacodynamics, 2016-04, Vol.43 (2), p.123-135

2016

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Mo1094 Pharmacometric Approach to Select Esomeprazole Doses in Pediatrics With GERD

Gastroenterology (New York, N.Y. 1943), 2012-05, Vol.142 (5), p.S-594-S-594

2012

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Quantitative Dynamic Models of Arthritis Progression in the Rat

Pharmaceutical research, 2009-01, Vol.26 (1), p.196-203

2009

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Down-regulation of heat shock protein 70 improves arsenic trioxide and 17-DMAG effects on constitutive signal transducer and activator of transcription 3 activity

Cancer chemotherapy and pharmacology, 2010-09, Vol.66 (4), p.681-689

2010

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Synergism between Arsenic Trioxide and Heat Shock Protein 90 Inhibitors on Signal Transducer and Activator of Transcription Protein 3 Activity—Pharmacodynamic Drug-Drug Interaction Modeling

Clinical cancer research, 2007-04, Vol.13 (7), p.2261-2270

2007

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Pharmacokinetics of dexamethasone in a rat model of rheumatoid arthritis

Biopharmaceutics & drug disposition, 2008-09, Vol.29 (6), p.366-372

2008

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Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction

Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA

Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic

Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices

Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Reply to White et al

Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria

FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions: A Review of 198 Submissions Between 2000 and 2008

A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development

The Utility of a Population Approach in Drug–Drug Interaction Assessments: A Simulation Evaluation

Modeling corticosteroid effects in a rat model of rheumatoid arthritis I: mechanistic disease progression model for the time course of collagen-induced arthritis in Lewis rats

Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response

Utility of population pharmacokinetic modeling in the assessment of therapeutic protein-drug interactions

Therapeutic Protein Drug–Drug Interactions: Navigating the Knowledge Gaps–Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop

Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations

Modeling corticosteroid effects in a rat model of rheumatoid arthritis II: mechanistic pharmacodynamic model for dexamethasone effects in Lewis rats with collagen-induced arthritis

Methods and strategies for assessing uncontrolled drug–drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group

Mo1094 Pharmacometric Approach to Select Esomeprazole Doses in Pediatrics With GERD

Quantitative Dynamic Models of Arthritis Progression in the Rat

Down-regulation of heat shock protein 70 improves arsenic trioxide and 17-DMAG effects on constitutive signal transducer and activator of transcription 3 activity

Synergism between Arsenic Trioxide and Heat Shock Protein 90 Inhibitors on Signal Transducer and Activator of Transcription Protein 3 Activity—Pharmacodynamic Drug-Drug Interaction Modeling

Pharmacokinetics of dexamethasone in a rat model of rheumatoid arthritis

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