Leslie Z. Benet

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All published works

Action	Title	Year	Authors
+	Commentary: Pharmacokinetic Theory Must Consider Published Experimental Data	2024	Leslie Z. Benet Jasleen K. Sodhi
+ PDF Chat	An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing	2024	Hirokazu Wakuda Yue Xiang Jasleen K. Sodhi Naoto Uemura Leslie Z. Benet
+ PDF Chat	Calculating Pharmacokinetic Areas	2022	Leslie Z. Benet Anu Patel Hirokazu Wakuda Ava Y Xu
+ PDF Chat	Does Addition of Protein to Hepatocyte or Microsomal In Vitro Incubations Provide a Useful Improvement in In Vitro-In Vivo Extrapolation Predictability?	2022	Tsubasa Kameyama Jasleen K. Sodhi Leslie Z. Benet
+	Can <i>In Vitro–In Vivo</i> Extrapolation Be Successful? Recognizing the Incorrect Clearance Assumptions	2021	Leslie Z. Benet Jasleen K. Sodhi
+	Batch Selection via In Vitro/In Vivo Correlation in Pharmacokinetic Bioequivalence Testing	2021	Elise Burmeister Getz Kevin J. Carroll Johanna Mielke Byron Jones Leslie Z. Benet
+	Batch‐to‐Batch and Within‐Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?	2019	Leslie Z. Benet Priya Jayachandran Kevin J. Carroll Elise Burmeister Getz
+	Predicting human liver toxicity using in vitro measures: Can past failures lead to future success?	2019	Leslie Z. Benet
+	Why Drugs Fail in Late Stages of Development: Case Study Analyses from the Last Decade and Recommendations	2018	Dolly A. Parasrampuria Leslie Z. Benet Amarnath Sharma
+ PDF Chat	Inclusion of Placebos and Blinding for Ascending Dose First‐in‐Human Studies and Other Underpowered Phase 1 Studies has not been Justified and on Balance is Not Useful	2014	Dolly A. Parasrampuria Leslie Z. Benet
+	Lead PK Commentary: Predicting Human Pharmacokinetics	2011	Malcolm Rowland Leslie Z. Benet
+	Intermittent drug dosing intervals guided by the operational multiple dosing half lives for predictable plasma accumulation and fluctuation	2011	Anita Grover Leslie Z. Benet
+	Relevance of pharmacokinetics in narrow therapeutic index drugs	1999	Leslie Z. Benet
+	Bioequivalence and Narrow Therapeutic Index Drugs	1995	Leslie Z. Benet Jere E. Goyan
+	Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development	1994	Carl C. Peck William H. Barr Leslie Z. Benet Jerry M. Collins Robert E. Desjardins Daniel E. Furst John G. Harter Gerhard Levy Thomas M. Ludden John H. Rodman
+	The Role of Pharmacokinetics in the Drug Development Process	1993	Leslie Z. Benet
+	Opportunities for Integration of Pharmacokinetics, Pharmacodynamics and Toxicokinetics in Rational Drug Development	1993	Carl C. Peck William H. Barr Leslie Z. Benet Jerry M. Collins Robert E. Desjardins Daniel E. Furst John G. Harter Gerhard Levy Thomas M. Ludden John H. Rodman
+	Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development	1993	Avraham Yacobi Jerome P. Skelly Vinod P. Shah Leslie Z. Benet
+	Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development	1992	Carl C. Peck William H. Barr Leslie Z. Benet Jerry M. Collins Robert E. Desjardins Daniel E. Furst John G. Harter Gerhard Levy Thomas M. Ludden John H. Rodman
+	Opportunities for integration of pharmacokinetics, pharmacodynamics and toxicokinetics in rational drug development	1992	Carl C. Peck William H. Barr Leslie Z. Benet Jerry M. Collins Robert E. Desjardins Daniel E. Furst John G. Harter Gerhard Levy Thomas M. Ludden John H. Rodman
+	Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development.	1992	Carl C. Peck William H. Barr Leslie Z. Benet Jerry M. Collins Robert E. Desjardins Daniel E. Furst John G. Harter Gerhard Levy Thomas M. Ludden John H. Rodman
+	An integrated approach to pharmacokinetic analysis for linear mammillary systems in which input and exit may occur in/from any compartment	1989	Emi Nakashima Leslie Z. Benet
+	Mean residence time in the body versus mean residence time in the central compartment	1985	Leslie Z. Benet
+	Pharmacometrics: A new journal section	1982	Leslie Z. Benet Malcolm Rowland
+	A standard approach to compiling clinical pharmacokinetic data	1981	Lewis B. Sheiner Leslie Z. Benet Louis A. Pagliaro
+	Drug Pharmacokinetics in Cardiac and Hepatic Disease	1980	Roger Williams Leslie Z. Benet

Common Coauthors

Coauthor	Papers Together
Vinod P. Shah	6
Lewis B. Sheiner	6
Jerome P. Skelly	6
Avraham Yacobi	6
Gerhard Levy	5
Lilly Sanathanan	5
C. T. Viswanathan	5
Jerry M. Collins	5
Jerome J. Schentag	5
Daniel E. Furst	5
Carl C. Peck	5
William H. Barr	5
John G. Harter	5
Thomas M. Ludden	5
John H. Rodman	5
Robert E. Desjardins	5
Donald R. Stanski	5
Robert J. Temple	5
Jasleen K. Sodhi	4
Judi Weissinger	4
Elise Burmeister Getz	2
Malcolm Rowland	2
Hirokazu Wakuda	2
Dolly A. Parasrampuria	2
Kevin J. Carroll	2
Roger Williams	1
Jere E. Goyan	1
Emi Nakashima	1
Naoto Uemura	1
Louis A. Pagliaro	1
Ava Y Xu	1
Amarnath Sharma	1
Anu Patel	1
Priya Jayachandran	1
Yue Xiang	1
Byron Jones	1
Johanna Mielke	1
Anita Grover	1
Tsubasa Kameyama	1
Judy Weissinger	1

Commonly Cited References

Action	Title	Year	Authors	# of times referenced
+	Learning versus confirming in clinical drug development*	1997	Lewis B. Sheiner	2
+	General treatment of mean residence time, clearance, and volume parameters in linear mammillary models with elimination from any compartment	1988	Emi Nakashima Leslie Z. Benet	2
+	Commentary on “The Universally Unrecognized Assumption in Predicting Drug Clearance and Organ Extraction Ratio”	2017	Malcolm Rowland K. Sandy Pang	2
+	Biological determinants of propranolol disposition in man	1978	David M. Kornhauser Andrew J. Wood R. E. Vestal G. Wilkinson Robert A. Branch David G. Shand	2
+	Can <i>In Vitro–In Vivo</i> Extrapolation Be Successful? Recognizing the Incorrect Clearance Assumptions	2021	Leslie Z. Benet Jasleen K. Sodhi	2
+	Batch‐to‐batch pharmacokinetic variability confounds current bioequivalence regulations: A dry powder inhaler randomized clinical trial	2016	Elise Burmeister Getz KJ Carroll Byron Jones LZ Benet	2
+	Between‐Batch Pharmacokinetic Variability Inflates Type I Error Rate in Conventional Bioequivalence Trials: A Randomized Advair Diskus Clinical Trial	2016	Elise Burmeister Getz KJ Carroll Johanna Mielke LZ Benet Byron Jones	2
+	Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review	2010	Ping Zhao L Zhang Joseph A. Grillo Q. Liu Julie Bullock Young‐Jin Moon Pengfei Song Satjit Brar Rajanikanth Madabushi Ta C. Wu	1
+	Adverse events in phase-I studies: a report in 1015 healthy volunteers	1998	M. Sibille N. Deigat A. Janin Stéphane Kirkesseli D. Vital Durand	1
+	When is a seamless study desirable? Case studies from different pharmaceutical sponsors	2014	Robert L. Cuffe David Lawrence Andrew Stone Marc Vandemeulebroecke	1
+	Sample size determination for the two one-sided tests procedure in bioequivalence	1992	Jen‐pei Liu Shein‐Chung Chow	1
+ PDF Chat	Novel bioequivalence approach for narrow therapeutic index drugs	2014	LX Yu Wenlei Jiang Xinyuan Zhang Robert Lionberger F. Makhlouf DJ Schuirmann Laurie Muldowney M-L. Chen Barbara M. Davit Dale P. Conner	1
+	Elevation of Liver Enzymes in Multiple Dose Trials During Placebo Treatment: Are They Predictable?	1997	Michael Merz Michael Seiberling G Höxter M. Hölting H. Wortha	1
+	Pharmacokinetics and Bioavailability of a New Formulation of Teicoplanin following Intravenous and Intramuscular Administration to Humans	1991	Kelly K. Antony Eric Lewis Michael T. Kenny Jacqueline K. Dulworth Marcia B. Brackman R Kuzma Lianng Yuh Mark G. Eller Gary A. Thompson	1
+	Mean residence time in the body versus mean residence time in the central compartment	1985	Leslie Z. Benet	1
+	A new statistical procedure for testing equivalence in two-group comparative bioavailability trials	1984	Walter W. Hauck Sharon Anderson	1
+	Evaluation of the Cohort Size in Phase I Dose Escalation Trials Based on Laboratory Data	2003	Camilla Buöen Sture Holm Mikael S. Thomsen	1
+	Interpatient variability in bioavailability is related to the extent of absorption: Implications for bioavailability and bioequivalence studies	1996	Edward T. Hellriegel Thorir D. Bjornsson Walter W. Hauck	1
+	Power of the two one-sided tests procedure in bioequivalence	1990	Kem F. Phillips	1
+ PDF Chat	The Utility of Modeling and Simulation in Drug Development and Regulatory Review	2013	Shiew-Mei Huang Darrell R. Abernethy Yaning Wang Ping Zhao Issam Zineh	1
+ PDF Chat	Transaminase elevation on placebo during Phase I trials: prevalence and significance	1999	Rosenzweig Miget Brohier	1
+	Systems Pharmacology for Drug Discovery and Development: Paradigm Shift or Flash in the Pan?	2013	P. Vicini Piet H. van der Graaf	1
+	Rationale for Sponsor-unblinded Phase 1 Trials: Challenging the Double-blind Paradigm	2010	Jitendra Ganju Clapton Dias	1
+ PDF Chat	Comparing Generic and Innovator Drugs: A Review of 12 Years of Bioequivalence Data from the United States Food and Drug Administration	2009	Barbara M. Davit Patrick E. Nwakama Gary Buehler Dale P. Conner Sam Haidar Dewrat T Patel Yongsheng Yang Lawrence X. Yu Janet Woodcock	1
+	BiDil for Heart Failure in Black Patients: The U.S. Food and Drug Administration Perspective	2007	Robert Temple Norman Stockbridge	1
+	Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval	2003	Carl C. Peck	1
+	Pharmacokinetic/Pharmacodynamic Modeling in Drug Development	2000	Lewis B. Sheiner Jean‐Louis Steimer	1
+	Bioequivalence and Narrow Therapeutic Index Drugs	1995	Leslie Z. Benet Jere E. Goyan	1
+	How First‐Time‐in‐Human Studies Are Being Performed: A Survey of Phase I Dose‐Escalation Trials in Healthy Volunteers Published Between 1995 and 2004	2005	Camilla Buöen Ole J. Bjerrum Mikael S. Thomsen	1
+	The Serum Digitalis Concentration — Does It Diagnose Digitalis Toxicity?	1976	Joseph A. Ingelfinger Peter Goldman	1
+	Limitations of model based dose selection for indacaterol in patients with chronic obstructive pulmonary disease	2012	Yaning Wang Joo Yeon Lee Theresa M. Michele Badrul A. Chowdhury Jogarao Gobburu	1
+	Pharmacokinetic parameters: which are necessary to define a drug substance?	1984	Benet Lz	1
+	Effects of age and cigarette smoking on propranolol disposition	1979	R. E. Vestal Andrew J. Wood Robert A. Branch David G. Shand G. Wilkinson	1
+	Intravenous propranolol administration: A method for rapidly achieving and sustaining desired plasma levels	1976	R. G. McAllister	1
+	Disposition of propranolol V. Drug accumulation and steady‐state concentrations during chronic oral administration in man	1973	Gwyn H. Evans David G. Shand	1
+	Use of statistical and pharmacokinetic–pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference	2017	Holly Kimko Seth Berry Michael O’Kelly Nitin Mehrotra Matthew M. Hutmacher Venkat Sethuraman	1
+ PDF Chat	The Universally Unrecognized Assumption in Predicting Drug Clearance and Organ Extraction Ratio	2017	LZ Benet S Liu Alan R. Wolfe	1
+ PDF Chat	Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability	2021	Elise Burmeister Getz Kevin J. Carroll J. David Christopher Beth Morgan Scott Haughie Alessandro Cavecchi Christopher Wiggenhorn Hayden Beresford Helen Strickland Svetlana Lyapustina	1
+	Bioequivalence revisited	1992	Lewis B. Sheiner	1
+	Pharmacokinetics during Drug Development: Data Analysis and Evaluation Techniques.	1983	F. W. Harpley G Bozler J. M. van Rossum	1
+ PDF Chat	An Explanation of Why Dose-Corrected Area Under the Curve for Alternate Administration Routes Can Be Greater than for Intravenous Dosing	2024	Hirokazu Wakuda Yue Xiang Jasleen K. Sodhi Naoto Uemura Leslie Z. Benet	1
+	Statistical Simulation Study of New Proposed Uniformity Requirement for Bioequivalency Studies	1981	John D. Haynes	1
+	Adverse events in volunteers participating in phase I clinical trials: a single-center five-year survey in 1,559 subjects	2005	A. Lutfullin J. Kuhlmann Georg Wensing	1
+	Estimation of population characteristics of pharmacokinetic parameters from routine clinical data	1977	Lewis B. Sheiner Barr Rosenberg Vinay V. Marathe	1
+	Model-Based Meta-Analysis: An Important Tool for Making Quantitative Decisions During Drug Development	2012	Diane R. Mould	1
+	Symmetrical Confidence Intervals for Bioequivalence Trials	1976	Wilfred J. Westlake	1
+ PDF Chat	A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability	1987	Donald J. Schuirmann	1