Search Results - "Lesko, J"

Perspective on model‐informed drug development by Lesko, Lawrence J.

“…Model‐informed drug development (MIDD) is a process intended to expedite drug development, enhance regulatory science, and produce benefits for patients…”
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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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Modeling the variable amplitude fatigue of composite materials: A review and evaluation of the state of the art for spectrum loading by Post, N.L., Case, S.W., Lesko, J.J.

“…In this article, we review the experimental research and modeling of fiber reinforced polymer composite materials subjected to variable amplitude fatigue. In…”
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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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Fiber-Reinforced Polymer Composites for Construction-State-of-the-Art Review by Bakis, C. E, Bank, Lawrence C, Brown, V. L, Cosenza, E, Davalos, J. F, Lesko, J. J, Machida, A, Rizkalla, S. H, Triantafillou, T. C

“…A concise state-of-the-art survey of fiber-reinforced polymer (also known as fiber-reinforced plastic) composites for construction applications in civil…”
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Osteonecrosis of the Jaw in the United States Food and Drug Administration's Adverse Event Reporting System (FAERS) by Zhang, Xiaoyan, Hamadeh, Issam S, Song, Shuang, Katz, Joseph, Moreb, Jan S, Langaee, Taimour Y, Lesko, Lawrence J, Gong, Yan

“…ABSTRACT Osteonecrosis of the jaw (ONJ) is a serious adverse drug event that was initially reported with intravenous bisphosphonates (BPs) and more recently…”
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Durability Gap Analysis for Fiber-Reinforced Polymer Composites in Civil Infrastructure by Karbhari, V. M, Chin, J. W, Hunston, D, Benmokrane, B, Juska, T, Morgan, R, Lesko, J. J, Sorathia, U, Reynaud, D

“…The lack of a comprehensive, validated, and easily accessible data base for the durability of fiber-reinforced polymer (FRP) composites as related to civil…”
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Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective by Lesko, Lawrence J, Woodcock, Janet

“…Pharmacogenomics and pharmacogenetics provide methodologies that can lead to DNA-based tests to improve drug selection, identify optimal dosing, maximize drug…”
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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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Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues by Gage, Brian F., Lesko, Lawrence J.

“…Using pharmacogenetics-based therapy, clinicians can estimate the therapeutic warfarin dose by genotyping patients for single nucleotide polymorphisms (SNPs)…”
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Efficacy From Strange Sources by Lesko, Lawrence J.

“…Reverse translation (RT) refers to perceptions and observations of clinical outcomes, both beneficial and harmful, that can lead to a hypothesis intended to…”
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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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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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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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Development and validation of a LC–MS/MS assay for quantification of cisplatin in rat plasma and urine by Shaik, Abdul Naveed, Altomare, Deborah A., Lesko, Lawrence J., Trame, Mirjam N.

“…•Cisplatin LC–MS/MS Method Validation using Agilent 6460 triple quad.•Derivatization of cisplatin with diethyldithiocarbamate for indirect estimation of…”
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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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The Critical Path of Warfarin Dosing: Finding an Optimal Dosing Strategy Using Pharmacogenetics by Lesko, LJ

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Pharmacogenomic Biomarker Information in Drug Labels Approved by the United States Food and Drug Administration: Prevalence of Related Drug Use by Frueh, Felix W., Amur, Shashi, Mummaneni, Padmaja, Epstein, Robert S., Aubert, Ronald E., DeLuca, Teresa M., Verbrugge, Robert R., Burckart, Gilbert J., Lesko, Lawrence J.

“…Study Objectives. To review the labels of United States Food and Drug Administration (FDA)‐approved drugs to identify those that contain pharmacogenomic…”
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DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA by Lesko, Lawrence J, Zineh, Issam

“…Over the past 10 years, the US FDA has become a strong pharmacogenomics advocate as part of its mission to both protect and advance public health by enabling…”
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