Search Results - "Lesko, L J"

Individualization of Drug Therapy: History, Present State, and Opportunities for the Future by Lesko, L J, Schmidt, S

“…Individualization of drug therapy, described as tailoring drug selection and drug dosing to a given patient, has been an objective of physicians and other…”
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Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review by Zhao, P, Zhang, L, Grillo, JA, Liu, Q, Bullock, JM, Moon, YJ, Song, P, Brar, SS, Madabushi, R, Wu, TC, Booth, BP, Rahman, NA, Reynolds, KS, Gil Berglund, E, Lesko, LJ, Huang, S‐M

“…Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can help predict the pharmacokinetics of drugs in humans and evaluate the…”
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Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling by Huang, S‐M, Temple, R, Throckmorton, D C, Lesko, L J

“…One of the most effective ways in which regulatory agencies communicate with sponsors and guide drug development is through the issuance of guidances or…”
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Personalized Medicine: Elusive Dream or Imminent Reality? by Lesko, L J

“…The market for molecular diagnostic tests is predicted to grow at extraordinary rates over the next 10 years, fueled by pharmacogenetics and the elusive dream…”
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Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models by Zhang, X‐Y, Trame, MN, Lesko, LJ, Schmidt, S

“…A systems pharmacology model typically integrates pharmacokinetic, biochemical network, and systems biology concepts into a unifying approach. It typically…”
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Transporter-Mediated Drug-Drug Interactions by Zhang, L, Huang, S‐M, Lesko, LJ

“…Transporters are membrane‐bound proteins that control the access of endogenous and xenobiotics (drugs) to various sites in the human body. They influence drug…”
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Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision? by Lesko, L J

“…It has been almost 3 years since the launch of the FDA critical path initiative following the publication of the paper “Innovation or Stagnation: Challenges…”
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Therapeutic Protein-Drug Interactions and Implications for Drug Development by Huang, S‐M, Zhao, H, Lee, J‐I, Reynolds, K, Zhang, L, Temple, R, Lesko, L J

“…Many intrinsic and extrinsic factors can affect an individual patient's drug exposure and response.1 The US Food and Drug Administration (FDA) has published a…”
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Anticoagulants: What is new and what is the standard? by Lesko, LJ

“…This commentary focuses on the status of oral anticoagulants, namely, warfarin and the novel oral anticoagulants (NOACs) such as dabigatran, rivaroxaban,…”
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The Critical Path of Warfarin Dosing: Finding an Optimal Dosing Strategy Using Pharmacogenetics by Lesko, LJ

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Pharmacological Mechanism-Based Drug Safety Assessment and Prediction by Abernethy, DR, Woodcock, J, Lesko, LJ

“…Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to…”
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Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications by Zhang, Y, Zhang, L, Abraham, S, Apparaju, S, Wu, T‐C, Strong, JM, Xiao, S, Atkinson, AJ, Thummel, KE, Leeder, JS, Lee, C, Burckart, GJ, Lesko, LJ, Huang, S‐M

“…The US Food and Drug Administration (FDA) is currently developing a guidance for industry to replace a previous guidance, “Pharmacokinetics in Patients With…”
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When to Conduct a Renal Impairment Study During Drug Development: US Food and Drug Administration Perspective by Huang, S‐M, Temple, R, Xiao, S, Zhang, L, Lesko, LJ

“…To optimize drug therapy for individuals, it is critical to understand how various intrinsic (e.g., age, gender, race, genetics, organ impairment) and…”
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Physiologically Based Pharmacokinetics Is Impacting Drug Development and Regulatory Decision Making by Rowland, M, Lesko, LJ, Rostami‐Hodjegan, A

“…It is no coincidence that the reports of two meetings, one organized by the US Food and Drug Administration (FDA), in March 2014, and the other by the UK…”
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Quantitative Analysis to Guide Orphan Drug Development by Lesko, L J

“…The development of orphan drugs for rare diseases has made impressive strides in the past 10 years. There has been a surge in orphan drug designations, but new…”
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Systems Approaches in Risk Assessment by Lesko, L J, Zheng, S, Schmidt, S

“…Adverse drug events (ADEs) remain a universal problem in drug development, regulatory review, and clinical practice with a substantial financial burden on the…”
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Application of Physiologically Based Pharmacokinetic Modeling to Predict Acetaminophen Metabolism and Pharmacokinetics in Children by Jiang, X‐L, Zhao, P, Barrett, JS, Lesko, LJ, Schmidt, S

“…Acetaminophen (APAP) is a widely used analgesic and antipyretic drug that undergoes extensive phase I and II metabolism. To better understand the kinetics of…”
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Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies by Lesko, L J, Atkinson, Jr, A J

“…In the future, biomarkers will play an increasingly important role in all phases of drug development, including regulatory review. However, only a few of these…”
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Clopidogrel: A Case for Indication-Specific Pharmacogenetics by Johnson, J A, Roden, D M, Lesko, L J, Ashley, E, Klein, T E, Shuldiner, A R

“…The CYP2C19*2 loss‐of‐function allele is associated with reduced generation of active metabolites of clopidogrel. However, meta‐analyses have supported or…”
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Predicting Drug Interaction Potential With a Physiologically Based Pharmacokinetic Model: A Case Study of Telithromycin, a Time-Dependent CYP3A Inhibitor by Vieira, Md L T, Zhao, P, Berglund, E G, Reynolds, K S, Zhang, L, Lesko, L J, Huang, S-M

“…Telithromycin is a substrate and an inhibitor of cytochrome P450 3A (CYP3A4), with dose‐ and time‐dependent nonlinear pharmacokinetics (PK). We hypothesized…”
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