The AAPS Journal - Themed Issue

Population Pharmacokinetics — In Memory of Lewis Sheiner
Guest Editors: Peter Bonate and Diane Mould

Table of Contents

Population Pharmacokinetics: A Memorial Tribute to Lewis Sheiner
Diane R. Mould and Peter L. Bonate

Recommended Reading in Population Pharmacokinetic Pharmacodynamics
Peter L. Bonate

On Some “Disadvantages” of the Population Approach
Jerry R. Nedelman

Population Pharmacokinetics/Pharmacodynamics of Anesthetics
Erik Olofsen and Albert Dahan

Modeling and Simulation of Adherence: Approaches and Applications in Therapeutics
Leslie A. Kenna, Line Labbé, Jeffrey S. Barrett, and Marc Pfister

A Pragmatic Approach to the Design of Population Pharmacokinetic Studies
Amit Roy and Ene I. Ette

A Guide for Reporting the Results of Population Pharmacokinetic Analyses: A Swedish Perspective
Janet R. Wade, Monica Edholm, and Tomas Salmonson

Pharmacodynamic Parameter Estimation: Population Size Versus Number of Samples
Suzette Girgis, Sudhakar M. Pai, Ihab G. Girgis, and Vijay K. Batra

Evidence of Effectiveness: How Much Can We Extrapolate From Existing Studies?
Howard Lee, Dong-Seok Yim, Honghui Zhou, and Carl C. Peck

Population Pharmacokinetic Studies in Pediatrics: Issues in Design and Analysis
Bernd Meibohm, Stephanie Läer, John C. Panetta, and Jeffrey S. Barrett

Challenges in the Transition to Model-Based Development
Thaddeus H. Grasela, Jill Fiedler-Kelly, Cynthia A. Walawander, Joel S. Owen, Brenda B. Cirincione, Kathleen E. Reitz, Elizabeth A. Ludwig, Julie A. Passarell, and Charles W. Dement

Impact of Pharmacometrics on Drug Approval and Labeling Decisions: A Survey of 42 New Drug Applications
Venkatesh A. Bhattaram, Brian P. Booth, Roshni P. Ramchandani, B. Nhi Beasley, Yaning Wang, Veneeta Tandon, John Z. Duan, Raman K. Baweja, Patrick J. Marroum, Ramana S. Uppoor, Nam Atiqur Rahman, Chandrahas G. Sahajwalla, J. Robert Powell, Mehul U. Mehta, and Jogarao V. S. Gobburu

Model-Based Development of Gemcabene, a New Lipid-Altering Agent
Jaap W. Mandema, David Hermann, Wenping Wang, Tim Sheiner, Mark Milad, Rebecca Bakker-Arkema, and Daniel Hartman

A New Equivalence Based Metric for Predictive Check to Qualify Mixed-Effects Models
Pravin R. Jadhav and Jogarao V.S. Gobburu

Pharmacokinetics/Pharmacodynamics and the Stages of Drug Development: Role of Modeling and Simulation
Jenny Y. Chien, Stuart Friedrich, Michael A. Heathman, Dinesh P. de Alwis, and Vikram Sinha

Pharmacokinetic-Pharmacodynamic Modeling in the Data Analysis and Interpretation of Drug-induced QT/QTc Prolongation
Vladimir Piotrovsky

It’s Time
Brian P. Smith