Lawrence Lesko

Lawrence Lesko, Ph.D.

Professor Emeritus

Department: Pharmaceutics
Business Email: llesko@cop.ufl.edu

About Lawrence Lesko

Lawrence J. Lesko, Ph.D., F.C.P. joined the UF Research and Academic Center in Lake Nona (Orlando) in July 2011.

Before joining UF, Dr. Lesko worked nearly 20 years in the Food and Drug Administration’s Center for Drug Evaluation and Research as the Director of the Office of Clinical Pharmacology. He was also Chair of the Clinical Pharmacology Coordinating Subcommittee of the FDA’s Medical Policy Coordinating Committee and authored or co-authored numerous Guidance for Industry, and started the FDA’s Voluntary Genomics Data Submission Program and Mechanistic Drug Safety Program.

Lesko has published more than 200 peer-reviewed scientific publications and is a frequent invited national and international speaker in clinical pharmacology, personalized medicine, pharmacometrics and systems pharmacology. His research interests include drug development and regulatory science, quantitative clinical pharmacology and pharmacogenomics.

In 2011, Lesko received the Gary Neil Prize for Innovation in Drug Development from the American Society of Clinical Pharmacology and Therapeutics (ASCPT). He also received the Coriell Scientific Leadership Award for Personalized Medicine (2010), the Rawls-Palmer Progress in Medicine award from ASCPT (2007), the University of North Carolina Institute for Pharmacogenomics and Individualized Therapy Award for Clinical Service (2007), and the Nathanial B. Kwit Distinguished Service Award for Clinical Pharmacology from the American College of Clinical Pharmacology (2007). Lesko served as President of the American College of Clinical Pharmacology in 2004-2006. He is a Fellow in the Japanese Society for the Study of Xenobiotics, American College of Clinical Pharmacology and the American Association of Pharmaceutical Scientists. He is Board Certified in Clinical Pharmacology and a registered pharmacist.

Publications

2021
Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy.
Annual review of pharmacology and toxicology. 61:225-245 [DOI] 10.1146/annurev-pharmtox-033020-113257. [PMID] 33035445.
2021
Physiologically-based pharmacokinetics modeling to investigate formulation factors influencing the generic substitution of dabigatran etexilate.
CPT: pharmacometrics & systems pharmacology. [DOI] 10.1002/psp4.12589. [PMID] 33449439.
2020
A Review on Drug-Induced Nephrotoxicity: Pathophysiological Mechanisms, Drug Classes, Clinical Management, and Recent Advances in Mathematical Modeling and Simulation Approaches.
Clinical pharmacology in drug development. 9(8):896-909 [DOI] 10.1002/cpdd.879. [PMID] 33025766.
2020
Association of Oral Anticoagulants and Verapamil or Diltiazem With Adverse Bleeding Events in Patients With Nonvalvular Atrial Fibrillation and Normal Kidney Function.
JAMA network open. 3(4) [DOI] 10.1001/jamanetworkopen.2020.3593. [PMID] 32329770.
2020
FDALabel for drug repurposing studies and beyond.
Nature biotechnology. 38(12):1378-1379 [DOI] 10.1038/s41587-020-00751-0. [PMID] 33235392.
2020
Quantitative Systems Pharmacology Model-Based Predictions of Clinical Endpoints to Optimize Warfarin and Rivaroxaban Anti-Thrombosis Therapy.
Frontiers in pharmacology. 11 [DOI] 10.3389/fphar.2020.01041. [PMID] 32765265.
2020
Semi-mechanistic modelling platform to assess cardiac contractility and haemodynamics in preclinical cardiovascular safety profiling of new molecular entities.
British journal of pharmacology. 177(15):3568-3590 [DOI] 10.1111/bph.15079. [PMID] 32335903.
2020
Study of pharmacogenomic information in FDA-approved drug labeling to facilitate application of precision medicine.
Drug discovery today. 25(5):813-820 [DOI] 10.1016/j.drudis.2020.01.023. [PMID] 32032705.
2020
A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus.
Journal of pharmacokinetics and pharmacodynamics. 47(3):255-266 [DOI] 10.1007/s10928-020-09688-y. [PMID] 32335844.
2019
An Integrated Bioinformatics and Quantitative Modeling Approach to Investigate Potential Claims of Oral Generic Drug Product Bioinequivalence: Introduction.
Journal of clinical pharmacology. 59(9):1245-1248 [DOI] 10.1002/jcph.901. [PMID] 31087551.
2019
Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study.
Journal of clinical pharmacology. 59(9):1266-1274 [DOI] 10.1002/jcph.1433. [PMID] 31087554.
2019
Is Bioequivalence Established Based on the Reference-Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations.
Journal of clinical pharmacology. 59(8):1061-1069 [DOI] 10.1002/jcph.1380. [PMID] 30716169.
2019
Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products.
Journal of clinical pharmacology. 59(9):1252-1263 [DOI] 10.1002/jcph.1017. [PMID] 31087553.
2018
To Take or Not to Take With Meals? Unraveling Issues Related to Food Effects Labeling for Oral Antineoplastic Drugs.
Clinical pharmacology in drug development. 7(5):455-464 [DOI] 10.1002/cpdd.416. [PMID] 29197167.
2018
Regulatory Perspectives in Pharmacometric Models of Osteoporosis.
Journal of clinical pharmacology. 58(5):572-585 [DOI] 10.1002/jcph.1071. [PMID] 29485684.
2018
Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products.
Journal of pharmaceutical sciences. 107(10):2519-2530 [DOI] 10.1016/j.xphs.2018.06.013. [PMID] 29935299.
2018
Model-Informed Precision Dosing at the Bedside: Scientific Challenges and Opportunities.
CPT: pharmacometrics & systems pharmacology. 7(12):785-787 [DOI] 10.1002/psp4.12353. [PMID] 30255663.
2018
A pre-clinical quantitative model predicts the pharmacokinetics/pharmacodynamics of an anti-BDCA2 monoclonal antibody in humans.
Journal of pharmacokinetics and pharmacodynamics. 45(6):817-827 [DOI] 10.1007/s10928-018-9609-6. [PMID] 30377889.
2018
Establishing a Multidisciplinary Framework to Study Drug-Drug Interactions of Hormonal Contraceptives: An Invitation to Collaborate.
CPT: pharmacometrics & systems pharmacology. 7(11):706-708 [DOI] 10.1002/psp4.12357. [PMID] 30260082.
2018
Efficacy From Strange Sources.
Clinical pharmacology and therapeutics. 103(2):253-261 [DOI] 10.1002/cpt.916. [PMID] 29052220.
2018
A Semi-Mechanistic Population Pharmacokinetic Model of Nusinersen: An Antisense Oligonucleotide for the Treatment of Spinal Muscular Atrophy.
CPT: pharmacometrics & systems pharmacology. 7(9):581-592 [DOI] 10.1002/psp4.12323. [PMID] 30043511.
2018
Model-Based Approach to Predict Adherence to Protocol During Antiobesity Trials.
Journal of clinical pharmacology. 58(2):240-253 [DOI] 10.1002/jcph.994. [PMID] 28858397.
2017
Why has model-informed precision dosing not yet become common clinical reality? lessons from the past and a roadmap for the future.
Clinical pharmacology and therapeutics. 101(5):646-656 [DOI] 10.1002/cpt.659. [PMID] 28182269.
2017
Preemptive Panel-Based Pharmacogenetic Testing: The Time is Now.
Pharmaceutical research. 34(8):1551-1555 [DOI] 10.1007/s11095-017-2163-x. [PMID] 28466392.
2017
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. 1046:243-249 [DOI] 10.1016/j.jchromb.2016.11.027. [PMID] 28162967.
2017
Evaluation of the Potential for Drug Interactions With Patiromer in Healthy Volunteers.
Journal of cardiovascular pharmacology and therapeutics. 22(5):434-446 [DOI] 10.1177/1074248417691135. [PMID] 28585859.
2017
Identifying clinically relevant sources of variability: The clopidogrel challenge.
Clinical pharmacology and therapeutics. 101(2):264-273 [DOI] 10.1002/cpt.459. [PMID] 27557470.
2016
Anticoagulants: What is new and what is the standard?
Clinical pharmacology and therapeutics. 100(2):126-8 [DOI] 10.1002/cpt.400. [PMID] 27197625.
2016
Are We Getting the Best Return on Investment From Clinical Drug-Drug Interaction Studies?
Journal of clinical pharmacology. 56(5):555-8 [DOI] 10.1002/jcph.661. [PMID] 26470760.
2016
Development of a physiology-directed population pharmacokinetic and pharmacodynamic model for characterizing the impact of genetic and demographic factors on clopidogrel response in healthy adults.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 82:64-78 [DOI] 10.1016/j.ejps.2015.10.024. [PMID] 26524713.
2016
How Informative Are Drug-Drug Interactions of Gene-Drug Interactions?
Journal of clinical pharmacology. 56(10):1221-31 [DOI] 10.1002/jcph.743. [PMID] 27040602.
2016
Improving drug safety with a systems pharmacology approach.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 94:84-92 [DOI] 10.1016/j.ejps.2016.06.009. [PMID] 27287422.
2016
Osteonecrosis of the Jaw in the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS).
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 31(2):336-40 [DOI] 10.1002/jbmr.2693. [PMID] 26288087.
2016
Quantitative Systems Pharmacology Model to Predict the Effects of Commonly Used Anticoagulants on the Human Coagulation Network.
CPT: pharmacometrics & systems pharmacology. 5(10):554-564 [DOI] 10.1002/psp4.12111. [PMID] 27647667.
2016
Systems pharmacology to predict drug safety in drug development.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 94:93-95 [DOI] 10.1016/j.ejps.2016.05.027. [PMID] 27251780.
2015
Clinical pharmacokinetics and pharmacodynamics of clopidogrel.
Clinical pharmacokinetics. 54(2):147-66 [DOI] 10.1007/s40262-014-0230-6. [PMID] 25559342.
2015
Clinical Practice Recommendations on Genetic Testing of CYP2C9 and VKORC1 Variants in Warfarin Therapy.
Therapeutic drug monitoring. 37(4):428-36 [DOI] 10.1097/FTD.0000000000000192. [PMID] 26186657.
2015
Physiologically Based Pharmacokinetics Is Impacting Drug Development and Regulatory Decision Making.
CPT: pharmacometrics & systems pharmacology. 4(6):313-5 [DOI] 10.1002/psp4.52. [PMID] 26225258.
2015
Sobol Sensitivity Analysis: A Tool to Guide the Development and Evaluation of Systems Pharmacology Models.
CPT: pharmacometrics & systems pharmacology. 4(2):69-79 [DOI] 10.1002/psp4.6. [PMID] 27548289.
2014
Model-based assessment of dosing strategies in children for monoclonal antibodies exhibiting target-mediated drug disposition.
CPT: pharmacometrics & systems pharmacology. 3 [DOI] 10.1038/psp.2014.38. [PMID] 25271939.
2014
Clinical implementation of genetic testing in medicine: a US regulatory science perspective.
British journal of clinical pharmacology. 77(4):606-11 [DOI] 10.1111/bcp.12299. [PMID] 24286486.
2014
Pharmacogenetic Research in Partnership With American Indian and Alaska Native Communities
Pharmacogenomics. 15(9):1235-1241 [DOI] 10.2217/PGS.14.91. [PMID] 25141898.
2014
A Semi-Physiological Population Pharmacokinetic/Pharmacodynamic Model for the Development of a Bedside-Ready Dosing Algorithm for Clopidogrel.
Clinical Pharmacology & Therapeutics. 95(1)
2014
A Physiologically Based Pharmacokinetic Model of Gefitinib Disposition: From Rat To Man
Clinical Pharmacology & Therapeutics. 95(1)
2013
Systems approaches in risk assessment.
Clinical pharmacology and therapeutics. 93(5):413-24 [DOI] 10.1038/clpt.2013.29. [PMID] 23531724.
2013
Interview: An interview with Lawrence Lesko for Personalized Medicine.
Personalized medicine. 10(1):19-26 [DOI] 10.2217/pme.12.112. [PMID] 29783468.
2013
Evaluation of hepatic impairment dosing recommendations in FDA-approved product labels.
Journal of clinical pharmacology. 53(9):962-6 [DOI] 10.1002/jcph.128. [PMID] 23832278.
2013
An Interview With Lawrence Lesko for Personalized Medicine
Personalized Medicine. 10:19-26 [DOI] 10.2217/PME.12.112.
2013
Application of physiologically based pharmacokinetic modeling to predict acetaminophen metabolism and pharmacokinetics in children.
CPT: pharmacometrics & systems pharmacology. 2 [DOI] 10.1038/psp.2013.55. [PMID] 24132164.
2013
Application of Physiologically-Based Pharmaco-Kinetic (Pbpk) Model in Predicting Drug Metabolism and Pharmacokinetics in Pediatric Populations-a Case Study of Acetaminophen
Clinical Pharmacology & Therapeutics. 93
2012
Academia At the Crossroads: Education and Training in Pharmacogenomics
Personalized Medicine. 9:497-506 [DOI] 10.2217/PME.12.54.
2012
Academia at the crossroads: education and training in pharmacogenomics.
Personalized medicine. 9(5):497-506 [DOI] 10.2217/pme.12.54. [PMID] 29768769.
2012
Clopidogrel: a case for indication-specific pharmacogenetics.
Clinical pharmacology and therapeutics. 91(5):774-6 [DOI] 10.1038/clpt.2012.21. [PMID] 22513313.
2012
Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulation.
Journal of clinical pharmacology. 52(1 Suppl):91S-108S [DOI] 10.1177/0091270011415528. [PMID] 22232759.
2012
Individualization of drug therapy: history, present state, and opportunities for the future.
Clinical pharmacology and therapeutics. 92(4):458-66 [DOI] 10.1038/clpt.2012.113. [PMID] 22948891.
2012
Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor.
Clinical pharmacology and therapeutics. 91(4):700-8 [DOI] 10.1038/clpt.2011.305. [PMID] 22398966.
2012
Quantitative analysis to guide orphan drug development.
Clinical pharmacology and therapeutics. 92(2):258-61 [DOI] 10.1038/clpt.2012.80. [PMID] 22739138.
2012
Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease.
Journal of clinical pharmacology. 52(1 Suppl):79S-90S [DOI] 10.1177/0091270011415410. [PMID] 22232757.
2012
The Creating an Optimal Warfarin Nomogram (CROWN) Study.
Thrombosis and haemostasis. 107(1):59-68 [DOI] 10.1160/TH11-08-0568. [PMID] 22116191.
2012
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. 33(2):99-110 [DOI] 10.1002/bdd.1771. [PMID] 22270945.
2012
Drug research and translational bioinformatics.
Clinical pharmacology and therapeutics. 91(6):960-2 [DOI] 10.1038/clpt.2012.45. [PMID] 22609906.
2011
Transporter-mediated drug-drug interactions.
Clinical pharmacology and therapeutics. 89(4):481-4 [DOI] 10.1038/clpt.2010.359. [PMID] 21423238.
2011
Pharmacological mechanism-based drug safety assessment and prediction.
Clinical pharmacology and therapeutics. 89(6):793-7 [DOI] 10.1038/clpt.2011.55. [PMID] 21490594.
2011
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Clinical pharmacokinetics. 50(10):627-35 [DOI] 10.2165/11593210-000000000-00000. [PMID] 21895036.
2011
Clinical pharmacology as a cornerstone of orphan drug development.
Nature reviews. Drug discovery. 10(11):795-6 [DOI] 10.1038/nrd3595. [PMID] 22037026.
2011
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.
Clinical pharmacology and therapeutics. 89(2):259-67 [DOI] 10.1038/clpt.2010.298. [PMID] 21191381.
2011
Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label.
Clinical pharmacology and therapeutics. 90(3):471-4 [DOI] 10.1038/clpt.2011.149. [PMID] 21796114.
2010
What is clinical utility and why should we care?
Clinical pharmacology and therapeutics. 88(6):729-33 [DOI] 10.1038/clpt.2010.229. [PMID] 21081937.
2010
Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors.
Pharmacotherapy. 30(2):195-209 [DOI] 10.1592/phco.30.2.195. [PMID] 20099993.
2010
Therapeutic protein-drug interactions and implications for drug development.
Clinical pharmacology and therapeutics. 87(4):497-503 [DOI] 10.1038/clpt.2009.308. [PMID] 20200513.
2010
Pharmacogenomics and adverse drug reactions.
Personalized medicine. 7(6):633-642 [DOI] 10.2217/pme.10.63. [PMID] 29788561.
2010
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Nature reviews. Drug discovery. 9(6):435-45 [DOI] 10.1038/nrd3116. [PMID] 20514070.
2010
Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs.
Pharmacogenomics. 11(12):1637-47 [DOI] 10.2217/pgs.10.138. [PMID] 21142906.
2010
Food and oral antineoplastics: more than meets the eye.
Clinical cancer research : an official journal of the American Association for Cancer Research. 16(17):4305-7 [DOI] 10.1158/1078-0432.CCR-10-1857. [PMID] 20736331.
2010
DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA.
Pharmacogenomics. 11(4):507-12 [DOI] 10.2217/pgs.10.16. [PMID] 20350131.
2010
Cancer pharmacogenomics and pharmacoepidemiology: setting a research agenda to accelerate translation.
Journal of the National Cancer Institute. 102(22):1698-705 [DOI] 10.1093/jnci/djq390. [PMID] 20944079.
2010
Personalized medicine and genomics: challenges and opportunities in assessing effectiveness, cost-effectiveness, and future research priorities.
Medical decision making : an international journal of the Society for Medical Decision Making. 30(3):328-40 [DOI] 10.1177/0272989X09347014. [PMID] 20086232.
2009
4th US FDA-Drug Information Association pharmacogenomics workshop, held 10-12 December, 2007.
Pharmacogenomics. 10(1):111-5 [DOI] 10.2217/14622416.10.1.111. [PMID] 19102720.
2009
A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity.
Journal of clinical pharmacology. 49(2):138-46 [DOI] 10.1177/0091270008328098. [PMID] 19179293.
2009
Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications.
Clinical pharmacology and therapeutics. 85(3):305-11 [DOI] 10.1038/clpt.2008.208. [PMID] 19020495.
2009
Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with ‘what-ifs’.
Pharmacogenomics. 10(1):137-47 [DOI] 10.2217/14622416.10.1.137. [PMID] 19102723.
2009
Pharmacogenetics in medicine: barriers, critical factors and a framework for dialogue.
Personalized medicine. 6(4):359-361 [DOI] 10.2217/pme.09.27. [PMID] 29783536.
2009
Pharmacogenetics–tailoring treatment for the outliers.
The New England journal of medicine. 360(8):811-3 [DOI] 10.1056/NEJMe0810630. [PMID] 19228625.
2009
Quantitative disease, drug, and trial models.
Annual review of pharmacology and toxicology. 49:291-301 [DOI] 10.1146/annurev.pharmtox.011008.145613. [PMID] 18851702.
2009
When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective.
Clinical pharmacology and therapeutics. 86(5):475-9 [DOI] 10.1038/clpt.2009.190. [PMID] 19844224.
2008
A prototypical process for creating evidentiary standards for biomarkers and diagnostics.
Clinical pharmacology and therapeutics. 83(2):368-71 [PMID] 18091762.
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2008
Couma-Gen: implications for future randomized trials of pharmacogenetic-based warfarin therapy.
Personalized medicine. 5(2):163-168 [DOI] 10.2217/17410541.5.2.163. [PMID] 29783347.
2008
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
Journal of clinical pharmacology. 48(2):146-56 [DOI] 10.1177/0091270007311111. [PMID] 18199891.
2008
The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics.
Clinical pharmacology and therapeutics. 84(3):301-3 [DOI] 10.1038/clpt.2008.133. [PMID] 18714317.
2008
Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.
Pharmacotherapy. 28(8):992-8 [DOI] 10.1592/phco.28.8.992. [PMID] 18657016.
2008
Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective.
Biomarkers in medicine. 2(3):305-11 [DOI] 10.2217/17520363.2.3.305. [PMID] 20477416.
2008
New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance process.
Journal of clinical pharmacology. 48(6):662-70 [DOI] 10.1177/0091270007312153. [PMID] 18378963.
2008
Pharmacogenetics of warfarin: regulatory, scientific, and clinical issues.
Journal of thrombosis and thrombolysis. 25(1):45-51 [PMID] 17906972.
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2007
Drug interaction studies: study design, data analysis, and implications for dosing and labeling.
Clinical pharmacology and therapeutics. 81(2):298-304 [PMID] 17259955.
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2007
Impact of pharmacometric reviews on new drug approval and labeling decisions–a survey of 31 new drug applications submitted between 2005 and 2006.
Clinical pharmacology and therapeutics. 81(2):213-21 [PMID] 17259946.
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2007
Paving the critical path: how can clinical pharmacology help achieve the vision?
Clinical pharmacology and therapeutics. 81(2):170-7 [PMID] 17259944.
View on: PubMed
2007
Personalized medicine: elusive dream or imminent reality?
Clinical pharmacology and therapeutics. 81(6):807-16 [PMID] 17505496.
View on: PubMed
2007
The value meal: effect of food on lapatinib bioavailability.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 25(33):5333-4; author reply 5334 [PMID] 18024885.
View on: PubMed
2006
Application of pharmacogenomics in clinical pharmacology.
Toxicology mechanisms and methods. 16(2-3):89-99 [DOI] 10.1080/15376520600558333. [PMID] 20021001.
2006
Scientific perspectives on drug transporters and their role in drug interactions.
Molecular pharmaceutics. 3(1):62-9 [PMID] 16686370.
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2006
Three years of promise, proposals, and progress on optimizing the benefit/risk of medicines: a commentary on the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop.
The pharmacogenomics journal. 6(2):78-81 [PMID] 16402087.
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2005
The need for education in pharmacogenomics: a regulatory perspective.
The pharmacogenomics journal. 5(4):218-20 [PMID] 16041391.
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2004
Drug-drug, drug-dietary supplement, and drug-citrus fruit and other food interactions: what have we learned?
Journal of clinical pharmacology. 44(6):559-69 [PMID] 15145962.
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2004
Pharmacogenomic data: FDA voluntary and required submission guidance.
Pharmacogenomics. 5(5):503-5 [PMID] 15212586.
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2004
Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal.
Pharmacogenomics. 5(1):25-30 [PMID] 14683418.
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2004
Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.
Nature reviews. Drug discovery. 3(9):763-9 [PMID] 15340386.
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2003
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.
Journal of clinical pharmacology. 43(4):342-58 [PMID] 12723455.
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2003
Use of biomarkers from drug discovery through clinical practice: report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development.
Clinical pharmacology and therapeutics. 73(4):284-91 [PMID] 12709718.
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2003
Microarray data–the US FDA, industry and academia.
Nature biotechnology. 21(7):742-3 [PMID] 12833089.
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2002
Biopharmaceutics classification system: the scientific basis for biowaiver extensions.
Pharmaceutical research. 19(7):921-5 [PMID] 12180542.
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2002
The effect of amiloride on the in vivo effective permeability of amoxicillin in human jejunum: experience from a regional perfusion technique.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 15(3):271-7 [PMID] 11923059.
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2002
Pharmacogenomic-guided drug development: regulatory perspective.
The pharmacogenomics journal. 2(1):20-4 [PMID] 11990376.
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2002
Effect of St John’s wort on the pharmacokinetics of fexofenadine.
Clinical pharmacology and therapeutics. 71(6):414-20 [PMID] 12087344.
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2002
Medical applications of microarray technologies: a regulatory science perspective.
Nature genetics. 32 Suppl:474-9 [PMID] 12454641.
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2001
Bioavailability and bioequivalence: an FDA regulatory overview.
Pharmaceutical research. 18(12):1645-50 [PMID] 11785681.
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2001
Human jejunal permeability of two polar drugs: cimetidine and ranitidine.
Pharmaceutical research. 18(6):742-4 [PMID] 11474776.
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2001
Individual bioequivalence revisited.
Clinical pharmacokinetics. 40(10):701-6 [PMID] 11707058.
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2001
Influence of drug release properties of conventional solid dosage forms on the systemic exposure of highly soluble drugs.
AAPS pharmSci. 3(3) [PMID] 11741275.
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2001
Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: a conference report.
Clinical pharmacology and therapeutics. 69(6):387-99 [PMID] 11406736.
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2001
Measures of exposure versus measures of rate and extent of absorption.
Clinical pharmacokinetics. 40(8):565-72 [PMID] 11523723.
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2001
Pharmacokinetic-pharmacodynamic modeling of rivastigmine, a cholinesterase inhibitor, in patients with Alzheimer’s disease.
Journal of clinical pharmacology. 41(10):1082-90 [PMID] 11583476.
View on: PubMed
2001
The effects of St John’s wort (Hypericum perforatum) on human cytochrome P450 activity.
Clinical pharmacology and therapeutics. 70(4):317-26 [PMID] 11673747.
View on: PubMed
2001
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies.
Annual review of pharmacology and toxicology. 41:347-66 [PMID] 11264461.
View on: PubMed
2001
Variability in the bioavailability of phenytoin capsules in males and females.
Pharmaceutical research. 18(3):394-7 [PMID] 11442282.
View on: PubMed
2001
Limits of 80%-125% for AUC and 70%-143% for Cmax. What is the impact on bioequivalence studies?
International journal of clinical pharmacology and therapeutics. 39(8):350-5 [PMID] 11515710.
View on: PubMed
2000
Pharmacokinetic analysis of bioequivalence trials: implications for sex-related issues in clinical pharmacology and biopharmaceutics.
Clinical pharmacology and therapeutics. 68(5):510-21 [PMID] 11103754.
View on: PubMed
2000
Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.
European journal of drug metabolism and pharmacokinetics. 25(1):7-12 [PMID] 11032082.
View on: PubMed
2000
Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metoprolol tartrate tablet formulations.
AAPS PharmSciTech. 1(2) [PMID] 14727847.
View on: PubMed
2000
Pharmacokinetic/pharmacodynamic modeling in drug research and development.
Journal of clinical pharmacology. 40(12 Pt 2):1399-418 [PMID] 11185661.
View on: PubMed
2000
Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 10(4):iv-xiv [PMID] 11023342.
View on: PubMed
2000
Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Pharmaceutical research. 17(11):1335-44 [PMID] 11205725.
View on: PubMed
2000
In vivo drug-drug interaction studies–a survey of all new molecular entities approved from 1987 to 1997.
Clinical pharmacology and therapeutics. 68(3):280-5 [PMID] 11014409.
View on: PubMed
2000
Effect of troglitazone on cytochrome P450 enzymes in primary cultures of human and rat hepatocytes.
Xenobiotica; the fate of foreign compounds in biological systems. 30(3):273-84 [PMID] 10752642.
View on: PubMed
2000
Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives.
Journal of clinical pharmacology. 40(1):31-8 [PMID] 10631619.
View on: PubMed
2000
Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Journal of clinical pharmacology. 40(8):803-14 [PMID] 10934664.
View on: PubMed
1999
In vitro metabolic interaction studies: experience of the Food and Drug Administration.
Clinical pharmacology and therapeutics. 66(1):9-15 [PMID] 10430104.
View on: PubMed
1999
FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug interactions: impact on labeling.
Journal of clinical pharmacology. 39(9):899-910 [PMID] 10471980.
View on: PubMed
1999
Population pharmacokinetics. A regulatory perspective.
Clinical pharmacokinetics. 37(1):41-58 [PMID] 10451782.
View on: PubMed
1999
Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling.
Clinical pharmacology and therapeutics. 66(4):346-57 [PMID] 10546918.
View on: PubMed
1999
Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues.
Journal of clinical pharmacology. 39(10):1006-14 [PMID] 10516934.
View on: PubMed
1999
Evaluation of truncated areas in the assessment of bioequivalence of immediate release formulations of drugs with long half-lives and of Cmax with different dissolution rates.
Pharmaceutical research. 16(6):939-43 [PMID] 10397617.
View on: PubMed
1998
Bioequivalence of topical dermatological dosage forms–methods of evaluation of bioequivalence.
Pharmaceutical research. 15(2):167-71 [PMID] 9523299.
View on: PubMed
1998
Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II: Comparison of single and multiple-dose trials using AUC and Cmax.
Pharmaceutical research. 15(1):98-104 [PMID] 9487554.
View on: PubMed
1998
Evaluation of the proposed FDA pilot dose-response methodology for topical corticosteroid bioequivalence testing.
Pharmaceutical research. 15(1):4-7 [PMID] 9487539.
View on: PubMed
1998
Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets.
Pharmaceutical development and technology. 3(4):535-47 [PMID] 9834957.
View on: PubMed
1998
Lack of in vivo/in vitro correlations for 50 mg and 250 mg primidone tablets.
Pharmaceutical research. 15(7):1085-9 [PMID] 9688064.
View on: PubMed
1998
The impact of formulation and process changes on in vitro dissolution and the bioequivalence of piroxicam capsules.
Pharmaceutical development and technology. 3(4):443-52 [PMID] 9834946.
View on: PubMed
1998
The relative bioavailability and in vivo-in vitro correlations for four marketed carbamazepine tablets.
Pharmaceutical research. 15(11):1787-91 [PMID] 9834004.
View on: PubMed
1997
Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group.
Clinical pharmacokinetics. 33(1):1-6 [PMID] 9250419.
View on: PubMed
1997
Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations.
Pharmaceutical development and technology. 2(1):11-24 [PMID] 9552427.
View on: PubMed
1997
Human intestinal permeability of piroxicam, propranolol, phenylalanine, and PEG 400 determined by jejunal perfusion.
Pharmaceutical research. 14(9):1127-32 [PMID] 9327437.
View on: PubMed
1997
Defining the maximum tolerated dose: investigator, academic, industry and regulatory perspectives.
Journal of clinical pharmacology. 37(9):767-83 [PMID] 9549630.
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1997
Draft guidance for industry extended-release solid oral dosage forms. Development, evaluation and application of in vitro-in vivo correlations.
Advances in experimental medicine and biology. 423:269-88 [PMID] 9269503.
View on: PubMed
1996
Bioequivalence assessment of generic drugs: an American point of view.
European journal of drug metabolism and pharmacokinetics. 21(2):159-64 [PMID] 8839690.
View on: PubMed
1996
Evaluation of orally administered highly variable drugs and drug formulations.
Pharmaceutical research. 13(11):1590-4 [PMID] 8956322.
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1994
Psychotropic medications in oncology and in AIDS patients.
Advances in psychosomatic medicine. 21:107-37 [PMID] 7528461.
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1992
The effects of age on the pharmacokinetics and biotransformation of theophylline in vivo and in vitro in the Mongolian gerbil (Meriones unguiculatus).
Mechanisms of ageing and development. 66(2):173-86 [PMID] 1365843.
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1989
Cutaneous papillomatous hyperplasia in cyclosporine-A treated beagles.
The Journal of investigative dermatology. 93(2):224-30 [PMID] 2754276.
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1989
Cyclosporine-induced gingival overgrowth in beagle dogs.
Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology. 18(4):240-5 [PMID] 2769597.
View on: PubMed
1989
Pharmacokinetic drug interactions with amiodarone.
Clinical pharmacokinetics. 17(2):130-40 [PMID] 2673606.
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1988
Lymphocyte-mediated effects of cyclosporine on human fibroblasts.
Transplantation proceedings. 20(3 Suppl 3):993-1002 [PMID] 3388528.
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1988
Steady state relative bioavailability and pharmacokinetics of oral propranolol in black and white North Americans.
Biopharmaceutics & drug disposition. 9(5):447-56 [PMID] 3224162.
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1988
Effects of allostimulation and cyclosporine therapy on cytotoxic antibody production in highly sensitized prospective renal transplant recipients.
Transplantation. 46(4):591-4 [PMID] 3051568.
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1987
Evaluation of the effects of cyclosporine and HLA-typed source leukocyte transfusions (apheresis by-products) on the immune systems of highly sensitized prospective renal allograft recipients.
Transplantation proceedings. 19(1 Pt 1):735-7 [PMID] 3547838.
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1986
Pharmacokinetics and pharmacodynamics of nifedipine in patients at steady state.
Journal of clinical pharmacology. 26(8):587-92 [PMID] 3793948.
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1985
Pharmacokinetics and pharmacodynamics of milrinone in chronic congestive heart failure.
The American journal of cardiology. 56(10):685-9 [PMID] 4050707.
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1984
Vancomycin disposition: the importance of age.
Clinical pharmacology and therapeutics. 36(6):803-10 [PMID] 6499360.
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1982
Acute pharmacodynamics and pharmacokinetics of oral amrinone.
Journal of clinical pharmacology. 22(10):425-32 [PMID] 7174852.
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1981
Procainamide interference with liquid chromatography of theophylline in serum.
Therapeutic drug monitoring. 3(1):107-8 [PMID] 7233485.
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1981
Theophylline serum protein binding in obstructive airways disease.
Clinical pharmacology and therapeutics. 29(6):776-81 [PMID] 7226709.
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1980
Two reasons for unusual therapeutic drug monitoring results in hospitalized patients.
Therapeutic drug monitoring. 2(3):217-9 [PMID] 7222175.
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1979
Dose-dependent elimination kinetics of theophylline.
Clinical pharmacokinetics. 4(6):449-59 [PMID] 519931.
View on: PubMed

Grants

Apr 2015 – Aug 2017
Pharmacogenomics of Oxydocone in Chronic Pain Management
Role: Principal Investigator
Funding: RAJ ENTERPRISES OF CENTRAL FLORIDA LLC
Sep 2014 – Aug 2018
A Model- and Systems-based Approach to Efficacy and Safety Questions Related to Generic Substitution
Role: Project Manager
Funding: US FOOD AND DRUG ADMN
Jun 2014 – Apr 2016
Vertex – Cystic Fibrosis Research
Role: Principal Investigator
Funding: VERTEX PHARMACEUTICALS
Mar 2014 – Mar 2016
Application of Population Pharmacokinetic/Pharmacodynamic Modeling and Simulation to Design an Effective Drug Development Program for Demonstrating Longitudinal Weight Loss and Identifying Covariates Influencing Weight Loss Maintenance
Role: Principal Investigator
Funding: TAKEDA PHARMACEUTICALS INTERNATIONAL
Apr 2013 – Apr 2016
Educational Grant Agreement
Role: Principal Investigator
Funding: DAIICHI PHARMACEUTICAL PHARM CORP

Education

Ph.D.
1971 · Temple University Health Science Center
B.S.
1967 · Temple University Health Science Center

Teaching Profile

Courses Taught
2012,2014-2018,2018
PHA7980 Research for Doctoral Dissertation
2012,2014-2016
PHA7979 Advanced Research
2014-2015
PHA6938 Research Seminar
2014
PHA5907 Research in Phar Prac

Contact Details

Emails:
Business:
llesko@cop.ufl.edu