Recommended reading in population pharmacokinetic pharmacodynamics

Developing the skills or expertise to create useful population pharmacokinetic-pharmacodynamic models can be a daunting task-the level of mathematical and statistical complexity is such that newcomers to the field are frequently overwhelmed. A good place to start in learning the field is to read articles in the literature. However, the number of articles dealing with population pharmacokinetic pharmacodynamics is exponentially increasing on a yearly basis, so choosing which articles to read can be difficult. The purpose of this review is to provide a recommended reading list for newcomers to the field. The list was chosen based on perceived impact of the article in the field, the quality of the article, or to highlight some important detail contained within the article. After reading the articles in the list, it is believed that the reader will have a broad overview of the field and have a sound foundation for moredetailed reading of the literature.

[1]  G. Molenberghs,et al.  Linear Mixed Models for Longitudinal Data , 2001 .

[2]  Stephen B. Duffull,et al.  Prospective Evaluation of a D-Optimal Designed Population Pharmacokinetic Study , 2003, Journal of Pharmacokinetics and Pharmacodynamics.

[3]  Mats O. Karlsson,et al.  Assumption Testing in Population Pharmacokinetic Models: Illustrated with an Analysis of Moxonidine Data from Congestive Heart Failure Patients , 1998, Journal of Pharmacokinetics and Biopharmaceutics.

[4]  Marie Davidian,et al.  Consequences of misspecifying assumptions in nonlinear mixed effects models , 2000 .

[5]  Mats O. Karlsson,et al.  Assessment of Actual Significance Levels for Covariate Effects in NONMEM , 2001, Journal of Pharmacokinetics and Pharmacodynamics.

[6]  Lewis B. Sheiner,et al.  Pharmacokinetic parameter estimates from several least squares procedures: Superiority of extended least squares , 1985, Journal of Pharmacokinetics and Biopharmaceutics.

[7]  Peter I D Lee,et al.  Design and Power of A Population Pharmacokinetic Study , 2004, Pharmaceutical Research.

[8]  R B Smith,et al.  An evaluation of population pharmacokinetics in therapeutic trials. Part II. Detection of a drug‐drug interaction , 1987, Clinical pharmacology and therapeutics.

[9]  L B Sheiner,et al.  Population pharmacokinetics/dynamics. , 1992, Annual review of pharmacology and toxicology.

[10]  Geert Molenberghs,et al.  Linear Mixed Models in Practice , 1997 .

[11]  Stephen B. Duffull,et al.  The use of simulated annealing for finding optimal population designs , 2002, Comput. Methods Programs Biomed..

[12]  Lewis B. Sheiner,et al.  A population pharmacokinetic model for docetaxel (Taxotere®): Model building and validation , 1996, Journal of Pharmacokinetics and Biopharmaceutics.

[13]  R. Tibshirani,et al.  Generalized Additive Models , 1991 .

[14]  Lewis B. Sheiner,et al.  Evaluation of methods for estimating population pharmacokinetic parameters II. Biexponential model and experimental pharmacokinetic data , 1981, Journal of Pharmacokinetics and Biopharmaceutics.

[15]  M. Gastonguay,et al.  Population Pharmacokinetics of Ciprofloxacin in Pediatric Patients , 2003, Journal of clinical pharmacology.

[16]  Lewis B. Sheiner,et al.  Extended least squares nonlinear regression: A possible solution to the “choice of weights” problem in analysis of individual pharmacokinetic data , 1984, Journal of Pharmacokinetics and Biopharmaceutics.

[17]  T H Grasela,et al.  Neonatal population pharmacokinetics of phenobarbital derived from routine clinical data. , 1985, Developmental pharmacology and therapeutics.

[18]  L B Sheiner,et al.  Population Pharmacokinetics of Procainamide from Routine Clinical Data , 1984, Clinical pharmacokinetics.

[19]  Peter L. Bonate,et al.  The Effect of Collinearity on Parameter Estimates in Nonlinear Mixed Effect Models , 1999, Pharmaceutical Research.

[20]  D. Stanski,et al.  A three-step approach combining bayesian regression and NONMEM population analysis: Application to midazolam , 1991, Journal of Pharmacokinetics and Biopharmaceutics.

[21]  Mats O. Karlsson,et al.  Assessment of Type I Error Rates for the Statistical Sub-model in NONMEM , 2002, Journal of Pharmacokinetics and Pharmacodynamics.

[22]  Lewis B. Sheiner,et al.  Building population pharmacokineticpharmacodynamic models. I. Models for covariate effects , 1992, Journal of Pharmacokinetics and Biopharmaceutics.

[23]  M. Rietschel,et al.  Population pharmacokinetic analysis of mirtazapine , 2004, European Journal of Clinical Pharmacology.

[24]  Marie Davidian,et al.  Nonlinear Models for Repeated Measurement Data , 1995 .

[25]  Nicholas H. G. Holford,et al.  A Size Standard for Pharmacokinetics , 1996, Clinical pharmacokinetics.

[26]  Geert Molenberghs,et al.  Linear Mixed Models in Practice: A SAS-Oriented Approach , 1997 .

[27]  M. O. Karlsson,et al.  The importance of modeling interoccasion variability in population pharmacokinetic analyses , 1993, Journal of Pharmacokinetics and Biopharmaceutics.

[28]  D. Stram,et al.  Variance components testing in the longitudinal mixed effects model. , 1994, Biometrics.

[29]  K G Kowalski,et al.  Design evaluation for a population pharmacokinetic study using clinical trial simulations: a case study. , 2001, Statistics in medicine.

[30]  M. Karlsson,et al.  Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis , 2002, AAPS PharmSci.

[31]  F. Follath,et al.  Population pharmacokinetic parameters in patients treated with oral mexiletine , 2004, European Journal of Clinical Pharmacology.

[32]  Lewis B. Sheiner,et al.  Estimation of population characteristics of pharmacokinetic parameters from routine clinical data , 1977, Journal of Pharmacokinetics and Biopharmaceutics.

[33]  Nicholas H. G. Holford,et al.  Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource , 1998 .

[34]  Stuart L. Beal,et al.  Interaction between structural, statistical, and covariate models in population pharmacokinetic analysis , 1994, Journal of Pharmacokinetics and Biopharmaceutics.

[35]  Didier Concordet,et al.  Population pharmacokinetics/pharmacodynamics relationships of an anticancer drug. , 2003, Statistics in medicine.

[36]  M. Rowland,et al.  Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies , 2004, European Journal of Clinical Pharmacology.

[37]  Yong Ho Kim,et al.  Model Appropriateness and Population Pharmacokinetic Modeling , 2003, Journal of clinical pharmacology.

[38]  E. Antman,et al.  Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction. , 2003, British journal of clinical pharmacology.

[39]  J. Boissel,et al.  Inter-study variability in population pharmacokinetic meta-analysis: when and how to estimate it? , 2000, Journal of pharmaceutical sciences.

[40]  D. Bates,et al.  Mixed-Effects Models in S and S-PLUS , 2001 .

[41]  V. Carey,et al.  Mixed-Effects Models in S and S-Plus , 2001 .

[42]  Lewis B. Sheiner,et al.  Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: Routine clinical pharmacokinetic data , 1983, Journal of Pharmacokinetics and Biopharmaceutics.

[43]  Lewis B. Sheiner,et al.  Evaluation of methods for estimating population pharmacokinetic parameters. I. Michaelis-menten model: Routine clinical pharmacokinetic data , 1980, Journal of Pharmacokinetics and Biopharmaceutics.