FIND

researchers

DISCOVER

relevant articles

PROMOTE

your research

now for free

Lawrence Lesko

Research Profile

Organizations

United States Food and Drug Administration

Physiology

Geographic Areas

United States

Concepts & Ideas

Procedures

Occupations

Activities & Behaviors

Drug Approval

Chemicals & Drugs

Co-author Network

Publications

TOP 3
Lawrence J Lesko; S Schmidt
Individualization of drug therapy: history, present state, and opportunities for the future.
Julie A Johnson; T E Klein; Lawrence J Lesko; D M Roden; Euan Ashley; Alan R Shuldiner
Clopidogrel: a case for indication-specific pharmacogenetics.
Md L T Vieira; L Zhang; P Zhao; E G Berglund; Lawrence J Lesko; K S Reynolds; S-M Huang
Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor.

Register for free to view:

Visualized networks:

See your personal network in
sophisticated graphical views

GeoTargeted Searches:

Locate experts around the world
and connect with global collaborators

Research Profiles:

See the research activity
of experts around the globe

Geonetwork of Lawrence Lesko (preview)

Cities where this author has publications
Cities where co-authors of this author have publications

Flash Player Required

All Publications

2012: Lawrence J Lesko; S Schmidt
Individualization of drug therapy: history, present state, and opportunities for the future.
Clinical pharmacology and therapeutics 2012;92(4):458-66.
2012: Julie A Johnson; T E Klein; Lawrence J Lesko; D M Roden; Euan Ashley; Alan R Shuldiner
Clopidogrel: a case for indication-specific pharmacogenetics.
Clinical pharmacology and therapeutics 2012;91(5):774-6.
2012: Md L T Vieira; L Zhang; P Zhao; E G Berglund; Lawrence J Lesko; K S Reynolds; S-M Huang
Predicting drug interaction potential with a physiologically based pharmacokinetic model: a case study of telithromycin, a time-dependent CYP3A inhibitor.
Clinical pharmacology and therapeutics 2012;91(4):700-8.
2012: Joseph A Grillo; Eva Gil Berglund; Brian P Booth; Julie Bullock; Lawrence J Lesko; Min Lu; K Sandy Pang; Atiqur Rahman; Kathy Robie-Suh; Lei Zhang; Ping Zhao; Shiew-Mei Huang
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 2012;33(2):99-110.
2012: Ping Zhao; Jenny H Zheng; Eva Gil Berglund; Darrell R. Abernethy; Vikram Arya; Arthur J Atkinson; Joseph A Grillo; Lawrence J Lesko; K Sandy Pang; Kellie S Reynolds; Pengfei Song; Yuichi Sugiyama; Manuela de L T Vieira; Ta-Chen Wu; Lei Zhang; Shiew-Mei Huang
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 2012;52(1 Suppl):91S-108S.
2012: Lei Zhang; Ping Zhao; Vikram Arya; Lawrence J Lesko; Shen Xiao; Nancy Xu; Shiew-Mei Huang
Regulatory perspectives on designing pharmacokinetic studies and optimizing labeling recommendations for patients with chronic kidney disease.
Journal of clinical pharmacology 2012;52(1 Suppl):79S-90S.
2011: Edward D Bashaw; Gilbert Burckart; Rosane Charlab; Timothy R Coté; Christine E Garnett; Jogarao V S Gobburu; Shiew-Mei Huang; Christine D Le; Angela Y Men; Anne R Pariser; Lei Zhang; Lawrence J Lesko
Clinical pharmacology as a cornerstone of orphan drug development.
Nature reviews. Drug discovery 2011;10(11):795-6.
2011: Joo Yeon Lee; Lawrence J Lesko; Fang Li; Jiang Liu; Rajanikanth Madabushi; Anshu Marathe; Nitin Mehrotra; Christoffer Tornoe; Yaning Wang; Venkatesh Atul Bhattaram; Satjit Brar; Justin C Earp; Christine E Garnett; Jogarao V S Gobburu; Pravin R Jadhav; Kevin Krudys; Hao Zhu
Impact of pharmacometric analyses on new drug approval and labelling decisions: a review of 198 submissions between 2000 and 2008.
Clinical pharmacokinetics 2011;50(10):627-35.
2011: D Menon-Andersen; Norman Stockbridge; R Temple; Ramana S Uppoor; B Yu; W Hao; Thomas Laughren; Lawrence J Lesko; Rajanikanth Madabushi; M Mehta; V Bhattaram; Jogarao V S Gobburu
Essential pharmacokinetic information for drug dosage decisions: a concise visual presentation in the drug label.
Clinical pharmacology and therapeutics 2011;90(3):471-4.
2011: Darrell R. Abernethy; J Woodcock; Lawrence J Lesko
Pharmacological mechanism-based drug safety assessment and prediction.
Clinical pharmacology and therapeutics 2011;89(6):793-7.
2011: L Zhang; Shiew-Mei Huang; Lawrence J Lesko
Transporter-mediated drug-drug interactions.
Clinical pharmacology and therapeutics 2011;89(4):481-4.
2011: P Zhao; L Zhang; J A Grillo; Q Liu; J M Bullock; Y J Moon; P Song; S S Brar; Rajanikanth Madabushi; T C Wu; Brian P Booth; N A Rahman; K S Reynolds; E Gil Berglund; Lawrence J Lesko; Shiew-Mei Huang
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review.
Clinical pharmacology and therapeutics 2011;89(2):259-67.
2010: Lawrence J Lesko; I Zineh; Shiew-Mei Huang
What is clinical utility and why should we care?
Clinical pharmacology and therapeutics 2010;88(6):729-33.
2010: Rajul K Jain; Satjit S Brar; Lawrence J Lesko
Food and oral antineoplastics: more than meets the eye.
Clinical cancer research : an official journal of the American Association for Cancer Research 2010;16(17):4305-7.
2010: Lawrence J Lesko; Issam Zineh
DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA.
Pharmacogenomics 2010;11(4):507-12.
2010: Shiew-Mei Huang; H Zhao; J-I Lee; K Reynolds; L Zhang; R Temple; Lawrence J Lesko
Therapeutic protein-drug interactions and implications for drug development.
Clinical pharmacology and therapeutics 2010;87(4):497-503.
2010: Jane P F Bai; Lawrence J Lesko; Gilbert J Burckart
Understanding the genetic basis for adverse drug effects: the calcineurin inhibitors.
Pharmacotherapy 2010;30(2):195-209.
2009: Shiew-Mei Huang; R Temple; S Xiao; L Zhang; Lawrence J Lesko
When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective.
Clinical pharmacology and therapeutics 2009;86(5):475-9.
2009: Y Zhang; L Zhang; Sophia Abraham; S Apparaju; T-C Wu; John M Strong; S Xiao; A J Atkinson; K E Thummel; J S Leeder; C Lee; Gilbert J Burckart; Lawrence J Lesko; Shiew-Mei Huang
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;85(3):305-11.
2009: Myong-Jin Kim; Shiew-Mei Huang; Urs A Meyer; Atiqur Rahman; Lawrence J Lesko
A regulatory science perspective on warfarin therapy: a pharmacogenetic opportunity.
Journal of clinical pharmacology 2009;49(2):138-46.
2009: Jogarao V S Gobburu; Lawrence J Lesko
Quantitative disease, drug, and trial models.
Annual review of pharmacology and toxicology 2009;49():291-301.
2008: Lawrence J Lesko
The critical path of warfarin dosing: finding an optimal dosing strategy using pharmacogenetics.
Clinical pharmacology and therapeutics 2008;84(3):301-3.
2008: Felix W Frueh; Shashi Amur; Padmaja Mummaneni; Robert S Epstein; Ronald E Aubert; Teresa M DeLuca; Robert R Verbrugge; Gilbert J Burckart; Lawrence J Lesko
Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.
Pharmacotherapy 2008;28(8):992-8.
2008: Shashi Amur; Felix W Frueh; Lawrence J Lesko; Shiew-Mei Huang
Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective.
Biomarkers in medicine 2008;2(3):305-11.
2008: Shiew-Mei Huang; John M Strong; Lei Zhang; Kellie S Reynolds; Srikanth Nallani; Robert Temple; Sophia Abraham; Sayed Al Habet; Raman K Baweja; Gilbert J Burckart; Sang Chung; Philip Colangelo; David Frucht; Martin D Green; Paul Hepp; Elena Karnaukhova; Hon-Sum Ko; Jang-Ik Lee; Patrick J Marroum; Janet M Norden; Wei Qiu; Atiqur Rahman; Solomon Sobel; Toni Stifano; Kenneth Thummel; Xiao-Xiong Wei; Sally Yasuda; Jenny H Zheng; Hong Zhao; Lawrence J Lesko
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;48(6):662-70.
2008: Yaning Wang; A Venkatesh Bhattaram; Pravin R Jadhav; Lawrence J Lesko; Rajanikanth Madabushi; J Robert Powell; Wei Qiu; He Sun; Dong S Yim; Jenny J Zheng; Jogarao V S Gobburu
Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006.
Journal of clinical pharmacology 2008;48(2):146-56.
2007: Shiew-Mei Huang; R Temple; D C Throckmorton; Lawrence J Lesko
Drug interaction studies: study design, data analysis, and implications for dosing and labeling.
Clinical pharmacology and therapeutics 2007;81(2):298-304.
2007: Venkatesh Atul Bhattaram; C Bonapace; D M Chilukuri; John Z Duan; C Garnett; Jogarao V S Gobburu; S H Jang; L Kenna; Lawrence J Lesko; Rajanikanth Madabushi; Y Men; J Robert Powell; W Qiu; Roshni P Ramchandani; C W Tornoe; Yaning Wang; J J Zheng
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 2007;81(2):213-21.
2007: Lawrence J Lesko
Paving the critical path: how can clinical pharmacology help achieve the vision?
Clinical pharmacology and therapeutics 2007;81(2):170-7.
2006: Ronald A Salerno; Lawrence J Lesko
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 2006;6(2):78-81.
2006: Shiew-Mei Huang; Federico M Goodsaid; Atiqur Rahman; Felix Frueh; Lawrence J Lesko
Application of pharmacogenomics in clinical pharmacology.
Toxicology mechanisms and methods 2006;16(2-3):89-99.
2006: Lei Zhang; John M Strong; Wei Qiu; Lawrence J Lesko; Shiew-Mei Huang
Scientific perspectives on drug transporters and their role in drug interactions.
Molecular pharmaceutics 2006;3(1):62-9.
2004: Lawrence X Yu; Arthur B Straughn; Patrick J Faustino; Yongsheng Yang; Ameeta Parekh; Anthony B Ciavarella; Ebenezer Asafu-Adjaye; Mehul U Mehta; Dale P Conner; Lawrence J Lesko; Ajaz Hussain
The effect of food on the relative bioavailability of rapidly dissolving immediate-release solid oral products containing highly soluble drugs.
Molecular pharmaceutics 2004;1(5):357-62.
2004: Lawrence J Lesko; Janet Woodcock
Translation of pharmacogenomics and pharmacogenetics: a regulatory perspective.
Nature reviews. Drug discovery 2004;3(9):763-9.
2004: Ronald A Salerno; Lawrence J Lesko
Pharmacogenomic data: FDA voluntary and required submission guidance.
Pharmacogenomics 2004;5(5):503-5.
2004: Shiew-Mei Huang; Lawrence J Lesko
Drug-drug, drug-dietary supplement, and drug-citrus fruit and other food interactions: what have we learned?
Journal of clinical pharmacology 2004;44(6):559-69.
2004: James E. Polli; Lawrence X Yu; Jack A Cook; Gordon L Amidon; Ronald T Borchardt; Beth A Burnside; Philip S Burton; Mei-Ling Chen; Dale P Conner; Patrick J Faustino; Amale A Hawi; Ajaz Hussain; Hemant N Joshi; Gloria Y Kwei; Vincent H L Lee; Lawrence J Lesko; Robert A Lipper; Alice E Loper; Shriniwas G Nerurkar; Joseph W Polli; Dilip R Sanvordeker; Rajneesh Taneja; Ramana S Uppoor; Chandra S Vattikonda; Ian Wilding; Guohua Zhang
Summary workshop report: biopharmaceutics classification system--implementation challenges and extension opportunities.
Journal of pharmaceutical sciences 2004;93(6):1375-81.
2004: Ronald A Salerno; Lawrence J Lesko
Pharmacogenomics in Drug Development and Regulatory Decision-making: the Genomic Data Submission (GDS) Proposal.
Pharmacogenomics 2004;5(1):25-30.
2003: Joseph L Hackett; Lawrence J Lesko
Microarray data--the US FDA, industry and academia.
Nature biotechnology 2003;21(7):742-3.
2003: Lawrence J Lesko; Ronald A Salerno; Brian B Spear; Donald C Anderson; Timothy Anderson; Celia Brazell; Jerry Collins; Andrew Dorner; David Essayan; Baltazar Gomez-Mancilla; Joseph Hackett; Shiew-Mei Huang; Susan Ide; Joanne Killinger; John Leighton; Elizabeth Mansfield; Robert Meyer; Stephen G Ryan; Virginia Schmith; Peter Shaw; Frank D Sistare; Mark Watson; Alexandra Worobec
Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.
Journal of clinical pharmacology 2003;43(4):342-58.
2003: Paul Rolan; Arthur J Atkinson; Lawrence J Lesko
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 2003;73(4):284-91.
2002: Emanuel F Petricoin; Joseph L Hackett; Lawrence J Lesko; Raj K Puri; Steven I Gutman; Konstantin Chumakov; Janet Woodcock; David W Feigal; Kathy Zoon; Frank D Sistare
Medical applications of microarray technologies: a regulatory science perspective.
Nature genetics 2002;32 Suppl():474-9.
2002: Lawrence X Yu; Gordon L Amidon; James E. Polli; Hong Zhao; Mehul U Mehta; Dale P Conner; Vinod P Shah; Lawrence J Lesko; Mei-Ling Chen; Vincent H L Lee; Ajaz Hussain
Biopharmaceutics classification system: the scientific basis for biowaiver extensions.
Pharmaceutical research 2002;19(7):921-5.
2002: Lawrence J Lesko; J Woodcock
Pharmacogenomic-guided drug development: regulatory perspective.
The pharmacogenomics journal 2002;2(1):20-4.
2001: Mei-Ling Chen; V Shah; RN Patnaik; W Adams; A Hussain; Dale P Conner; M Mehta; H Malinowski; J Lazor; S M Huang; D Hare; Lawrence J Lesko; D Sporn; Roger L Williams
Bioavailability and bioequivalence: an FDA regulatory overview.
Pharmaceutical research 2001;18(12):1645-50.
2001: Jogarao V S Gobburu; VK Tammara; Lawrence J Lesko; Stanford S Jhee; John J Sramek; Neal R Cutler; R Yuan
Pharmacokinetic-pharmacodynamic modeling of rivastigmine, a cholinesterase inhibitor, in patients with Alzheimer's disease.
Journal of clinical pharmacology 2001;41(10):1082-90.
2001: Walter W Hauck; A Parekh; Lawrence J Lesko; M L Chen; Roger L Williams
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 2001;39(8):350-5.
2001: G R Galluppi; Mark Rogge; Lorin K Roskos; Lawrence J Lesko; M D Green; David W Feigal; C C Peck
Integration of pharmacokinetic and pharmacodynamic studies in the discovery, development, and review of protein therapeutic agents: a conference report.
Clinical pharmacology and therapeutics 2001;69(6):387-99.
2001: Marvin C Meyer; Arthur B Straughn; RM Mhatre; Vinod P Shah; Mei-Ling Chen; Roger L Williams; Lawrence J Lesko
Variability in the bioavailability of phenytoin capsules in males and females.
Pharmaceutical research 2001;18(3):394-7.
2001: Lawrence X Yu; C D Ellison; D P Conner; Lawrence J Lesko; Ajaz Hussain
Influence of drug release properties of conventional solid dosage forms on the systemic exposure of highly soluble drugs.
AAPS pharmSci 2001;3(3):E24.
2001: Mei-Ling Chen; Lawrence J Lesko
Individual bioequivalence revisited.
Clinical pharmacokinetics 2001;40(10):701-6.
2001: Mei-Ling Chen; Lawrence J Lesko; Roger L Williams
Measures of exposure versus measures of rate and extent of absorption.
Clinical pharmacokinetics 2001;40(8):565-72.
2001: Lawrence J Lesko; A J Atkinson
Use of biomarkers and surrogate endpoints in drug development and regulatory decision making: criteria, validation, strategies.
Annual review of pharmacology and toxicology 2001;41():347-66.
2000: Hartmut Derendorf; Lawrence J Lesko; P Chaikin; W A Colburn; P Lee; R Miller; R Powell; G Rhodes; D Stanski; J Venitz
Pharmacokinetic/pharmacodynamic modeling in drug research and development.
Journal of clinical pharmacology 2000;40(12 Pt 2):1399-418.
2000: Lawrence J Lesko; M Rowland; CC Peck; TF Blaschke
Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Pharmaceutical research 2000;17(11):1335-44.
2000: Patrick J Marroum; Ramana S Uppoor; T Parmelee; FO Ajayi; A Burnett; R Yuan; R Svadjian; Lawrence J Lesko; JD Balian
In vivo drug-drug interaction studies--a survey of all new molecular entities approved from 1987 to 1997.
Clinical pharmacology and therapeutics 2000;68(3):280-5.
2000: Lawrence J Lesko; M Rowland; CC Peck; TF Blaschke
Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Journal of clinical pharmacology 2000;40(8):803-14.
2000: Natalie D. Eddington; GS Rekhi; Lawrence J Lesko; Larry L Augsburger
Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metoprolol tartrate tablet formulations.
AAPS PharmSciTech 2000;1(2):E14.
2000: Roger L Williams; W Adams; Mei-Ling Chen; D Hare; A Hussain; Lawrence J Lesko; RN Patnaik; V Shah
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 2000;25(1):7-12.
2000: Lawrence J Lesko; M Rowland; CC Peck; TF Blaschke; Douwe D Breimer; H J de Jong; A Grahnen; J J Kuhlmann; B Stewart
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 2000;10(4):iv-xiv.
2000: S Ibrahim; P Honig; Shiew-Mei Huang; W Gillespie; Lawrence J Lesko; Roger L Williams
Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives.
Journal of clinical pharmacology 2000;40(1):31-8.
1999: Gur Jai Pal Singh; Wallace P Adams; Lawrence J Lesko; Vinod P Shah; Justina A Molzon; Roger L Williams; Lynn K Pershing
Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling.
Clinical pharmacology and therapeutics 1999;66(4):346-57.
1999: Shiew-Mei Huang; Lawrence J Lesko; Roger L Williams
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 1999;39(10):1006-14.
1999: B Davit; K Reynolds; R Yuan; FO Ajayi; D Conner; EO Fadiran; B Gillespie; Chandra Sahajwalla; Shiew-Mei Huang; Lawrence J Lesko
FDA evaluations using in vitro metabolism to predict and interpret in vivo metabolic drug-drug interactions: impact on labeling.
Journal of clinical pharmacology 1999;39(9):899-910.
1999: R Yuan; T Parmelee; JD Balian; Ramana S Uppoor; FO Ajayi; A Burnett; Lawrence J Lesko; Patrick J Marroum
In vitro metabolic interaction studies: experience of the Food and Drug Administration.
Clinical pharmacology and therapeutics 1999;66(1):9-15.
1999: Pradeep M Sathe; Jürgen Venitz; Lawrence J Lesko
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 1999;16(6):939-43.
1998: Natalie D. Eddington; M Ashraf; Larry L Augsburger; J L Leslie; Michael Fossler; Lawrence J Lesko; Vinod P Shah; GS Rekhi
Identification of formulation and manufacturing variables that influence in vitro dissolution and in vivo bioavailability of propranolol hydrochloride tablets.
Pharmaceutical development and technology 1998;3(4):535-47.
1998: DA Piscitelli; S Bigora; C Propst; S Goskonda; P Schwartz; Lawrence J Lesko; Larry L Augsburger; D Young
The impact of formulation and process changes on in vitro dissolution and the bioequivalence of piroxicam capsules.
Pharmaceutical development and technology 1998;3(4):443-52.
1998: Marvin C Meyer; Arthur B Straughn; RM Mhatre; Vinod P Shah; Roger L Williams; Lawrence J Lesko
The relative bioavailability and in vivo-in vitro correlations for four marketed carbamazepine tablets.
Pharmaceutical research 1998;15(11):1787-91.
1998: Marvin C Meyer; Arthur B Straughn; RM Mhatre; Vinod P Shah; Roger L Williams; Lawrence J Lesko
Lack of in vivo/in vitro correlations for 50 mg and 250 mg primidone tablets.
Pharmaceutical research 1998;15(7):1085-9.
1998: Vinod P Shah; Gordon Flynn; A Yacobi; H I Maibach; C Bon; N M Fleischer; TJ Franz; S A Kaplan; J Kawamoto; Lawrence J Lesko; JP Marty; Lynn K Pershing; Hans Schaefer; JA Sequeira; Surendra P Shrivastava; Jonathan Wilkin; Roger L Williams
Bioequivalence of topical dermatological dosage forms--methods of evaluation of bioequivalence. AAPS/FDA Workshop on 'Bioequivalence of Topical Dermatological Dosage Forms-- Methods of Evaluating Bioequivalence', September 4-6, 1996, Bethesda, Md.
Skin pharmacology and applied skin physiology 1998;11(2):117-24.
1998: Vinod P Shah; Gordon Flynn; A Yacobi; H I Maibach; C Bon; N M Fleischer; TJ Franz; S A Kaplan; J Kawamoto; Lawrence J Lesko; JP Marty; Lynn K Pershing; Hans Schaefer; JA Sequeira; Surendra P Shrivastava; Jonathan Wilkin; Roger L Williams
Bioequivalence of topical dermatological dosage forms--methods of evaluation of bioequivalence.
Pharmaceutical research 1998;15(2):167-71.
1998: A A el-Tahtawy; T N Tozer; F Harrison; Lawrence J Lesko; Roger L Williams
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 1998;15(1):98-104.
1998: G J Singh; N Fleischer; Lawrence J Lesko; Roger L Williams
Evaluation of the proposed FDA pilot dose-response methodology for topical corticosteroid bioequivalence testing.
Pharmaceutical research 1998;15(1):4-7.
1997: Neal R Cutler; John J Sramek; D J Greenblatt; P Chaikin; N Ford; Lawrence J Lesko; B Davis; Roger L Williams
Defining the maximum tolerated dose: investigator, academic, industry and regulatory perspectives.
Journal of clinical pharmacology 1997;37(9):767-83.
1997: R N Patnaik; Lawrence J Lesko; M L Chen; Roger L Williams
Individual bioequivalence. New concepts in the statistical assessment of bioequivalence metrics. FDA Individual Bioequivalence Working Group.
Clinical pharmacokinetics 1997;33(1):1-6.
1997: GS Rekhi; Natalie D. Eddington; Michael Fossler; P Schwartz; Lawrence J Lesko; Larry L Augsburger
Evaluation of in vitro release rate and in vivo absorption characteristics of four metoprolol tartrate immediate-release tablet formulations.
Pharmaceutical development and technology 1997;2(1):11-24.
1996: Vinod P Shah; A Yacobi; W H Barr; L Z Benet; D Breimer; M R Dobrinska; L Endrenyi; W Fairweather; W Gillespie; M A Gonzalez; J Hooper; A Jackson; Lawrence J Lesko; K K Midha; P K Noonan; R Patnaik; Roger L Williams
Evaluation of orally administered highly variable drugs and drug formulations.
Pharmaceutical research 1996;13(11):1590-4.
1996: R Patnaik; Lawrence J Lesko; K Chan; Roger L Williams
Bioequivalence assessment of generic drugs: an American point of view.
European journal of drug metabolism and pharmacokinetics 1996;21(2):159-64.