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Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

Clinical pharmacology and therapeutics, 2011-02, Vol.89 (2), p.259-267

2011

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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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Individualization of Drug Therapy: History, Present State, and Opportunities for the Future

Clinical pharmacology and therapeutics, 2012-10, Vol.92 (4), p.458-466

2012

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Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling

Clinical pharmacology and therapeutics, 2007-02, Vol.81 (2), p.298-304

2007

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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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Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications

Clinical pharmacology and therapeutics, 2009-03, Vol.85 (3), p.305-311

2009

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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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Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models

CPT: pharmacometrics and systems pharmacology, 2015-02, Vol.4 (2), p.69-79

2015

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Personalized Medicine: Elusive Dream or Imminent Reality?

Clinical pharmacology and therapeutics, 2007-06, Vol.81 (6), p.807-816

Lesko, L J

2007

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Transporter-Mediated Drug-Drug Interactions

Clinical pharmacology and therapeutics, 2011-04, Vol.89 (4), p.481-484

2011

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Therapeutic Protein-Drug Interactions and Implications for Drug Development

Clinical pharmacology and therapeutics, 2010-04, Vol.87 (4), p.497-503

2010

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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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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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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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Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?

Clinical pharmacology and therapeutics, 2007-02, Vol.81 (2), p.170-177

Lesko, L J

2007

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Anticoagulants: What is new and what is the standard?

Clinical pharmacology and therapeutics, 2016-08, Vol.100 (2), p.126-128

Lesko, LJ

2016

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The Critical Path of Warfarin Dosing: Finding an Optimal Dosing Strategy Using Pharmacogenetics

Clinical pharmacology and therapeutics, 2008-09, Vol.84 (3), p.301-303

Lesko, LJ

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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Pharmacological Mechanism-Based Drug Safety Assessment and Prediction

Clinical pharmacology and therapeutics, 2011-06, Vol.89 (6), p.793-797

2011

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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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Biopharmaceutics classification system: The scientific basis for biowaiver extensions

Pharmaceutical research, 2002-07, Vol.19 (7), p.921-925

2002

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Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies

Annual review of pharmacology and toxicology, 2001-01, Vol.41 (1), p.347-366

2001

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When to Conduct a Renal Impairment Study During Drug Development: US Food and Drug Administration Perspective

Clinical pharmacology and therapeutics, 2009-11, Vol.86 (5), p.475-479

2009

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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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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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Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

Perspective on model‐informed drug development

Individualization of Drug Therapy: History, Present State, and Opportunities for the Future

Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling

Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective

Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications

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

Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models

Personalized Medicine: Elusive Dream or Imminent Reality?

Transporter-Mediated Drug-Drug Interactions

Therapeutic Protein-Drug Interactions and Implications for Drug Development

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

Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues

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

Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?

Anticoagulants: What is new and what is the standard?

The Critical Path of Warfarin Dosing: Finding an Optimal Dosing Strategy Using Pharmacogenetics

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

Pharmacological Mechanism-Based Drug Safety Assessment and Prediction

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

Biopharmaceutics classification system: The scientific basis for biowaiver extensions

Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies

When to Conduct a Renal Impairment Study During Drug Development: US Food and Drug Administration Perspective

Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel

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

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