Fundamentals of Population Pharmacokinetic Modelling Modelling and Software Tony K.L. Kiang, 1 Catherine M.T Sherwin, 2 Michael G. Spigarelli 2 and Mary H.H. Ensom 1,3 1 Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC, Canada 2 Division of Clinical Pharmacology & Clinical Trials Office, Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT, USA 3 Department of Pharmacy, Children’s and Women’s Health Centreof British Columbia, Vancouver, BC, Canada Contents Abstract ........................................................................................................... 515 1. Introduction .................................................................................................... 516 2. What is Population Pharmacokinetic Modelling? ..................................................................... 516 3. Fundamentals of Population Pharmacokinetic Modelling .............................................................. 517 4. Pharmacokinetic Software ........................................................................................ 518 4.1 Summary of Selected Software ................................................................................ 518 4.1.1 Data Input ........................................................................................... 518 4.1.2 Data Analysis ......................................................................................... 518 4.1.3 Data Output ......................................................................................... 519 4.1.4 System Requirements and Available Support .............................................................. 520 4.1.5 NONMEM â ........................................................................................... 520 4.1.6 MONOLIX ............................................................................................ 521 4.1.7 Pmetrics for MM-USCPACK ............................................................................. 521 4.1.8 Phoenix â NLMEä...................................................................................... 522 4.1.9 Kineticaä ............................................................................................ 522 4.1.10 S-ADAPT ............................................................................................. 522 4.2 Comparing the Performance of Software Programs .............................................................. 523 5. Future Approaches/Suggestions.................................................................................... 524 6. Conclusions ..................................................................................................... 524 Abstract Population pharmacokinetic modelling is widely used within the field of clinical pharmacology as it helps to define the sources and correlates of pharmacokinetic variability in target patient populations and their impact upon drug disposition. This review focuses on the fundamentals of population pharmacokinetic modelling and provides an overview of the commonly available software programs that perform these functions. This review attempts to define the common, fundamental aspects of population pharmacokinetic modelling through a discussion of the literature describing the techniques and placing them in the appro- priate context. An overview of the most commonly available software programs is also provided. Population pharmacokinetic modelling is a powerful approach where sources and correlates of pharmacokinetic variability can be identified in a target patient population receiving a pharmacological agent. There is a need to further standardize and establish the best approaches in modelling so that any REVIEW ARTICLE Clin Pharmacokinet 2012; 51 (8): 515-525 0312-5963/12/0008-0515/$49.95/0 Adis ª 2012 Springer International Publishing AG. All rights reserved.