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Perspective on model‐informed drug development

CPT: pharmacometrics and systems pharmacology, 2021-10, Vol.10 (10), p.1127-1129

Lesko, Lawrence J.

2021

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Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS)

Journal of bone and mineral research, 2016-02, Vol.31 (2), p.336-340

2016

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Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues

Journal of thrombosis and thrombolysis, 2008-02, Vol.25 (1), p.45-51

2008

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Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

Nature reviews. Drug discovery, 2004-09, Vol.3 (9), p.763-769

2004

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Development and validation of a LC–MS/MS assay for quantification of cisplatin in rat plasma and urine

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 2017-03, Vol.1046, p.243-249

2017

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Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Pharmacotherapy, 2008-08, Vol.28 (8), p.992-998

2008

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Advancing drug safety science by integrating molecular knowledge with post‐marketing adverse event reports

CPT: pharmacometrics and systems pharmacology, 2022-05, Vol.11 (5), p.540-555

2022

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Quantitative Systems Pharmacology Model-Based Predictions of Clinical Endpoints to Optimize Warfarin and Rivaroxaban Anti-Thrombosis Therapy

Frontiers in pharmacology, 2020-07, Vol.11, p.1041-1041

2020

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New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process

Journal of clinical pharmacology, 2008-06, Vol.48 (6), p.662-670

2008

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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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Pharmacodynamic Modeling to Evaluate the Impact of Cimetidine, an OCT2 Inhibitor, on the Anticancer Effects of Cisplatin

Cells (Basel, Switzerland), 2022-12, Vol.12 (1), p.57

2022

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Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel

Clinical pharmacokinetics, 2015-02, Vol.54 (2), p.147-166

2015

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Quantitative Disease, Drug, and Trial Models

Annual review of pharmacology and toxicology, 2009-01, Vol.49 (1), p.291-301

2009

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A case study of a patient‐centered reverse translational systems‐based approach to understand adverse event profiles in drug development

Clinical and translational science, 2022-04, Vol.15 (4), p.1003-1013

2022

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Application of a patient‐centered reverse translational systems‐based approach to understand mechanisms of an adverse drug reaction of immune checkpoint inhibitors

Clinical and translational science, 2022-06, Vol.15 (6), p.1430-1438

2022

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Physiologically‐based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate

CPT: pharmacometrics and systems pharmacology, 2021-03, Vol.10 (3), p.199-210

2021

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Preemptive Panel-Based Pharmacogenetic Testing: The Time is Now

Pharmaceutical research, 2017-08, Vol.34 (8), p.1551-1555

2017

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Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

Biopharmaceutics & drug disposition, 2012-03, Vol.33 (2), p.99-110

2012

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A Semi‐Mechanistic Population Pharmacokinetic Model of Nusinersen: An Antisense Oligonucleotide for the Treatment of Spinal Muscular Atrophy

CPT: pharmacometrics and systems pharmacology, 2018-09, Vol.7 (9), p.581-592

2018

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Efficacy From Strange Sources

Clinical pharmacology and therapeutics, 2018-02, Vol.103 (2), p.253-261

Lesko, Lawrence J.

2018

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Reflections on Model‐Informed Drug Development

Clinical pharmacology and therapeutics, 2024-08, Vol.116 (2), p.267-270

2024

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K1 - Model-informed precision dosing at the bedside: Challenges and opportunities

Drug metabolism and pharmacokinetics, 2020, Vol.35 (1), p.S5-S5

Lesko, Lawrence J.

2020

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Medical applications of microarray technologies: a regulatory science perspective

Nature genetics, 2002-12, Vol.32 Suppl (4s), p.474-479

2002

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A Regulatory Science Perspective on Warfarin Therapy: A Pharmacogenetic Opportunity

Journal of clinical pharmacology, 2009-02, Vol.49 (2), p.138-146

2009

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Effect of St John's wort on the pharmacokinetics of fexofenadine

Clinical pharmacology and therapeutics, 2002-06, Vol.71 (6), p.414-420

2002

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Perspective on model‐informed drug development

Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS)

Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues

Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

Development and validation of a LC–MS/MS assay for quantification of cisplatin in rat plasma and urine

Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use

Advancing drug safety science by integrating molecular knowledge with post‐marketing adverse event reports

Quantitative Systems Pharmacology Model-Based Predictions of Clinical Endpoints to Optimize Warfarin and Rivaroxaban Anti-Thrombosis Therapy

New Era in Drug Interaction Evaluation: US Food and Drug Administration Update on CYP Enzymes, Transporters, and the Guidance Process

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

Pharmacodynamic Modeling to Evaluate the Impact of Cimetidine, an OCT2 Inhibitor, on the Anticancer Effects of Cisplatin

Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel

Quantitative Disease, Drug, and Trial Models

A case study of a patient‐centered reverse translational systems‐based approach to understand adverse event profiles in drug development

Application of a patient‐centered reverse translational systems‐based approach to understand mechanisms of an adverse drug reaction of immune checkpoint inhibitors

Physiologically‐based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate

Preemptive Panel-Based Pharmacogenetic Testing: The Time is Now

Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice

A Semi‐Mechanistic Population Pharmacokinetic Model of Nusinersen: An Antisense Oligonucleotide for the Treatment of Spinal Muscular Atrophy

Efficacy From Strange Sources

Reflections on Model‐Informed Drug Development

K1 - Model-informed precision dosing at the bedside: Challenges and opportunities

Medical applications of microarray technologies: a regulatory science perspective

A Regulatory Science Perspective on Warfarin Therapy: A Pharmacogenetic Opportunity

Effect of St John's wort on the pharmacokinetics of fexofenadine

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