Research Topics
| Lawrence J LeskoSummaryAffiliation: Food and Drug Administration Country: USA Publications
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Publications
Personalized medicine: elusive dream or imminent reality?L J Lesko
Office of Clinical Pharmacology, FDA, Silver Spring, MD, USA
Clin Pharmacol Ther 81:807-16. 2007..They are well equipped to provide timely genetic education to others and to interpret genetic data so that actionable decisions, especially about drug dosing in individual patients, can be implemented in clinical practice...
DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDALawrence J Lesko
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US FDA, HFD 850, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
Pharmacogenomics 11:507-12. 2010....- The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogeneticsL J Lesko
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Clin Pharmacol Ther 84:301-3. 2008 - Paving the critical path: how can clinical pharmacology help achieve the vision?L J Lesko
Food and Drug Administration, Office of Clinical Pharmacology and Biopharmaceutics, Rockville Pike, Rockville, Maryland, USA
Clin Pharmacol Ther 81:170-7. 2007.... - Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney diseaseLei Zhang
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
J Clin Pharmacol 52:79S-90S. 2012..The objective of this article is to discuss the FDA's current recommendations and provide examples that illustrate the importance of and challenges in studying effect of renal impairment during drug development... - 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 practiceJoseph A Grillo
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, MD, USA
Biopharm Drug Dispos 33:99-110. 2012.... - New era in drug interaction evaluation: US Food and Drug Administration update on CYP enzymes, transporters, and the guidance processShiew Mei Huang
Office of Clinical Pharmacology, CDER, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
J Clin Pharmacol 48:662-70. 2008.... - Translation of pharmacogenomics and pharmacogenetics: a regulatory perspectiveLawrence J Lesko
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Nat Rev Drug Discov 3:763-9. 2004..Here, we consider this challenge from a regulatory perspective, highlighting recent initiatives from the FDA that aim to facilitate the integration of pharmacogenetics and pharmacogenomics into drug development and clinical practice... - A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunityMyong Jin Kim
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Rm 3188, Bldg 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
J Clin Pharmacol 49:138-46. 2009..Therefore, the purpose of this report is to review the current recommendations for warfarin therapy that involve genetic testing... - Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006Yaning Wang
Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
J Clin Pharmacol 48:146-56. 2008..A draft Guidance is being developed to be issued in 2008, and we hope this initiative will be resourced by then... - Quantitative disease, drug, and trial modelsJogarao V S Gobburu
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993 0002, USA
Annu Rev Pharmacol Toxicol 49:291-301. 2009..It requires a consorted effort by industry, academic, and regulatory scientists. We also describe the strategic goals of the FDA Pharmacometrics group... - Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe WorkshopLawrence J Lesko
Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland, USA
J Clin Pharmacol 43:342-58. 2003.... - Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008Joo Yeon Lee
Division of Pharmacometrics, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD, USA
Clin Pharmacokinet 50:627-35. 2011..Case studies are presented to better illustrate the role of pharmacometric analyses in regulatory decision making... - Evaluation of exposure change of nonrenally eliminated drugs in patients with chronic kidney disease using physiologically based pharmacokinetic modeling and simulationPing Zhao
Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
J Clin Pharmacol 52:91S-108S. 2012..The simulations demonstrate the utility and challenges of the PBPK approach in evaluating the pharmacokinetics of nonrenally cleared drugs in subjects with RI... - Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug useFelix W Frueh
Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U S Food and Drug Administration FDA, Silver Spring, MD 20993, USA
Pharmacotherapy 28:992-8. 2008.... - Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspectiveShashi Amur
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Building 51, 10903 New Hampshire Avenue, Silver Spring, MD 20993 0002, USA
Biomark Med 2:305-11. 2008..g., biomarkers for drug safety). In addition, the FDA has initiated the creation of various consortia that are working towards the identification and characterization of exploratory biomarkers in order to qualify them for a specific use... - Clinical pharmacology as a cornerstone of orphan drug developmentEdward D Bashaw
Office of Translational Sciences, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA
Nat Rev Drug Discov 10:795-6. 2011..A recent US Food and Drug Administration (FDA) advisory committee meeting highlighted the potential of clinical pharmacology to overcome challenges in orphan drug development... - Microarray data--the US FDA, industry and academiaJoseph L Hackett
Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, Maryland 20850, USA
Nat Biotechnol 21:742-3. 2003 - Drug-drug, drug-dietary supplement, and drug-citrus fruit and other food interactions: what have we learned?Shiew Mei Huang
Office of Clinical Pharmacology and Biopharmaceutics, HFD 850, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, PKLN 6A 19, Rockville, MD 20850, USA
J Clin Pharmacol 44:559-69. 2004..issues to consider in the interpretation of study results, and (3). recent labeling examples to illustrate the translation of study results to information useful for patients and health care providers... - Scientific perspectives on drug transporters and their role in drug interactionstLei Zhang
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, USA
Mol Pharm 3:62-9. 2006.... - Understanding the genetic basis for adverse drug effects: the calcineurin inhibitorsJane P F Bai
Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA
Pharmacotherapy 30:195-209. 2010..The disease-associated genes provide candidate genes for exploring ADEs and may provide genomic biomarkers for assessing the risk for developing severe calcineurin inhibitor-related ADEs as well as for developing preventive strategies... - Medical applications of microarray technologies: a regulatory science perspectiveEmanuel F Petricoin
Division of Therapeutic Products, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, FDA, Bethesda, Maryland 20892, USA
Nat Genet 32:474-9. 2002.... - Biopharmaceutics classification system: the scientific basis for biowaiver extensionsLawrence X Yu
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Rockville, Maryland 20857, USA
Pharm Res 19:921-5. 2002..3. Use the intrinsic dissolution method for solubility classification. 4. Define an intermediate solubility class for BCS Class II drugs. 5. Include surfactants in in vitro dissolution testing... - Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006V A Bhattaram
Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Clin Pharmacol Ther 81:213-21. 2007..PM analyses were ranked as important in regulatory decision making in over 85% of the 31 NDAs. Case studies are presented to demonstrate the applications of PM analysis... - Drug interaction studies: study design, data analysis, and implications for dosing and labelingS M Huang
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA
Clin Pharmacol Ther 81:298-304. 2007..In the past 10 years, clinical pharmacology guidances covering important areas have been issued, including pharmacokinetic data in patients with renal and hepatic impairment, dose-response studies, and drug-drug interactions... - 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 workshopR A Salerno
Worldwide Regulatory Affairs, Pharma and Translational Medicine, Wyeth Research, Collegeville, PA 19454, USA
Pharmacogenomics J 6:78-81. 2006 - Pharmacogenomic-guided drug development: regulatory perspectiveL J Lesko
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20852, USA
Pharmacogenomics J 2:20-4. 2002 - The need for education in pharmacogenomics: a regulatory perspectiveF W Frueh
Pharmacogenomics J 5:218-20. 2005 - Individual bioequivalence revisitedM L Chen
Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Pharmacokinet 40:701-6. 2001..Collection and analysis of bioequivalence data from replicate study designs may permit further assessment and resolution of these questions... - The effects of St John's wort (Hypericum perforatum) on human cytochrome P450 activityZ Wang
Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN 46202, USA
Clin Pharmacol Ther 70:317-26. 2001..St John's wort did not alter the CYP2C9, CYP1A2, or CYP2D6 activities. Reduced therapeutic efficacy of drugs metabolized by CYP3A should be anticipated during long-term administration of St John's wort...