Skip to main content
Log in

Recommended reading in population pharmacokinetic pharmacodynamics

  • Published:
The AAPS Journal Aims and scope Submit manuscript

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Sheiner LB, Rosenberg B, Marathe V. Estimation of population characteristics of pharmacokinetic parameters from routine clinical data.J Pharmacokinet Biopharm. 1977;5:445–479.

    Article  PubMed  CAS  Google Scholar 

  2. Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters. II. Biexponential model and experimental pharmacokinetic data.J Pharmacokinet Biopharm. 1981;9:635–651.

    Article  PubMed  CAS  Google Scholar 

  3. Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: routine pharmacokinetic data.J Pharmacokinet Biopharm. 1982;11:303–319.

    Article  Google Scholar 

  4. Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetics parameters. I. Michaelis-Menten model: routine clinical pharmacokinetic data.J Pharmacokinet Biopharm. 1980;8:553–571.

    Article  PubMed  CAS  Google Scholar 

  5. Peck CC, Beal SL, Sheiner LB, Nichols AI. Extended least squares nonlinear regression: a possible solution to the “choice of weights” problem in analysis of individual pharmacokinetic data.J Pharmacokinet Biopharm. 1984;12:545–558.

    Article  PubMed  CAS  Google Scholar 

  6. Sheiner LB, Beal SL. Pharmacokinetic parameter estimates from several least squares procedures: superiority of extended least squares.J Pharmacokinet Biopharm. 1985;13:185–201.

    Article  PubMed  CAS  Google Scholar 

  7. Vozeh S, Katz G, Steiner V, Follath F. Population pharmacokinetic parameters in patients treated with oral mexiletine.Eur J Clin Pharmacol. 1982;23:445–451.

    Article  PubMed  CAS  Google Scholar 

  8. Grasela TH, Sheiner LB. Population pharmacokinetics of procainamide from routine clinical data.Clin Pharmacokinet. 1984;9:545–554.

    Article  PubMed  CAS  Google Scholar 

  9. Grasela T, Donn SM. Neonatal population pharmacokinetics for phenobarbital derived from routine clinical data.Dev Pharmacol Ther. 1985;8:374–383.

    PubMed  Google Scholar 

  10. Grasela TH, Antal EJ, Ereshefsky L, Wells BG, Evans RL Smith RB. An evaluation of population pharmacokinetics in therapeutic trials. Part II. Detection of a drug-drug interaction.Clin Pharmacol Ther. 1987;42:433–441.

    Article  PubMed  Google Scholar 

  11. Wahlby U, Jonsson EN, Karlsson MO. Comparison of stepwise covariate model building strategies in population pharmacokinetic-pharmacodynamic analysis.AAPS PharmSci. 2002;4:E27.

    Article  PubMed  Google Scholar 

  12. Maitre PO, Buhrer M, Thomson D, Stanski DR. A three-step approach combining Bayesian regression and NONMEN population analysis: application to midazolam.J Pharmacokinet Biopharm. 1991;19:377–384.

    Article  PubMed  CAS  Google Scholar 

  13. Mandema J, Verotta D, Sheiner LB. Building population pharmacokinetic-pharmacodynamic models. I. Models for covariate effects.J Pharmacokinet Biopharm. 1992;20:511–528.

    Article  PubMed  CAS  Google Scholar 

  14. Hastie TJ, Tibshirani RJ.Generalized Additive Models. New York: Chapman and Hall. 1990.

    Google Scholar 

  15. Bruno R, Vivier N, Vergniol JC, DePhillips SL, Montay G, Sheiner LB. A population model for docetaxel (Taxotere®): model building and validation.J Pharmacokinet Biopharm. 1996;24:153–172.

    Article  PubMed  CAS  Google Scholar 

  16. Karlsson MO, Sheiner LB. The importance of modeling interoccasion variability in population pharmacokinetic analyses.J Pharmacokinet Biopharm. 1993;21:735–750.

    Article  PubMed  CAS  Google Scholar 

  17. Laporte-Simitsidis S, Girard P, Mismetti P, Chabaud S, Decousus H, Boissel JP. Inter-study variability in population pharmacokinetic analysis: when and how to estimate it?.J Pharm Sci. 2000;89:155–166.

    Article  PubMed  CAS  Google Scholar 

  18. Wade JR, Beal SL, Sambol NC. Interaction between structural, statistical, and covariate models in population pharmacokinetic analysis.J Pharmacokinet Biopharm. 1994;22:165–176.

    Article  PubMed  CAS  Google Scholar 

  19. Verbeke G, Molenberghs G.Linear Mixed Models in Practice: A SAS-Oriented Approach. New York: Springer Verlag: 1997.

    Google Scholar 

  20. Wahlby U, Jonsson EN, Karlsson MO. Assessment of actual significance levels for covariate effects in NONMEM.J Pharmacokinet Pharmacodyn. 2001;28:231–252.

    Article  PubMed  CAS  Google Scholar 

  21. Wahlby U, Bouw MR, Jonsson EN, Karlsson MO. Assessment of type I error rates for statistical sub-model in NONMEM.J Pharmacokinet Pharmacodyn. 2002;29:251–269.

    Article  PubMed  Google Scholar 

  22. Stram DO, Lee JW. Variance components testing in the longitudinal mixed effects model.Biometries. 1994;50:1171–1177.

    Article  CAS  Google Scholar 

  23. Pinheiro JC, Bates DM.Mixed-Effect Models in S and S-Plus. New York: Springer Verlag; 2000.

    Google Scholar 

  24. Aarons L, Balant LP, Mentre F, Morselli PL, Rowland M Steimer J-L, Vozeh S. Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies.Eur J Clin Pharmacol. 1996;49:251–254.

    Article  PubMed  CAS  Google Scholar 

  25. Kowalski K, Hutmacher MM. Design evaluation for a population pharmacokinetic study using clinical trial simulation: a case study.Stat Med. 2001;20:75–91.

    Article  PubMed  CAS  Google Scholar 

  26. Lee PID. Design and power of a population pharmacokinetic study.Pharm Res. 2001; 18:75–82.

    Article  PubMed  CAS  Google Scholar 

  27. Green D, Duffull SB. Prospective evaluation of a D-optimal designed population pharmacokinetic study.J Pharmacokinet Pharmacodyn. 2003;30:145–161.

    Article  PubMed  CAS  Google Scholar 

  28. Duffull SB, Retout S, Mentre F. The use of simulated annealing for finding optimal population designs.Comput Methods Programs Biomed. 2002; 69:25–35.

    Article  PubMed  Google Scholar 

  29. Karlsson MO, Jonsson EN, Wiltse CG, Wade JR. Assumption testing in population pharmacokinetic models: illustrated with an analysis of moxonidine data from congestive heart failure patients.J Pharmacokinet Biopharm. 1998;26:207–246.

    Article  PubMed  CAS  Google Scholar 

  30. Bonate PL. The effect of collinearity on parameter estimates in nonlinear mixed effect models.Pharm Res. 1999;16:709–717.

    Article  PubMed  CAS  Google Scholar 

  31. Hartford A, Davidian M. Consequences of misspecifying assumptions in nonlinear mixed effects models.Comp Stat Data Anal. 2000;34:139–164.

    Article  Google Scholar 

  32. Ette EI, Williams PJ, Kim YH, Lane JR, Liu M-J, Capparelli EV, Model appropriateness and pharmacokinetic modeling.J Clin Pharmacol. 2003;43:610–623.

    PubMed  CAS  Google Scholar 

  33. Bruno R, Baille P, Retout S, Vivier N, Veyrat-Follet C Sanderlink G-J, Becker R, Antman EM. Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction.Br J Clin Pharmacol. 2003;56:407–414.

    Article  PubMed  CAS  Google Scholar 

  34. Rajagopalan P, Gastonguay MR. Population pharmacokinetics of ciprofloxacin in pediatric patients.J Clin Pharmacol. 2003;43:698–710.

    PubMed  CAS  Google Scholar 

  35. Holford NHG. A size standard for pharmacokinetics.Clin Pharmacokinet. 1996;30:329–332.

    Article  PubMed  CAS  Google Scholar 

  36. Grasmader K, Verwohlt PL, Kuhn K-U, Dragicevic A, von Widdern O, Zobel A, Hiemke C, Rietschel M, Maier W, Jaehde U, Rao ML. Population pharmacokinetic analysis of mirtazapine.Eur J Clin Pharmacol. 2004;60:473–480.

    Article  PubMed  CAS  Google Scholar 

  37. Beal SL, Sheiner LB. Methodology of population pharmacokinetics. In: Garrett ER, Hirtz JL, eds.Drug Fate and Metabolism: Methods and Techniques. Vol. 5 New York: Marcel Dekker, Inc; 1985;135–183.

    Google Scholar 

  38. Sheiner LB, Ludden TM. Population pharmacokinetics/ pharmacodynamics.Annu Rev Pharmacol Toxicol. 1992;32:185–209.

    PubMed  CAS  Google Scholar 

  39. Tett S, Holford NHG, McLachlan AJ. Population pharmacokinetics and pharmacodynamics: an underutilized resource.Drug Inf J. 1998;32:693–710.

    Google Scholar 

  40. Davidian M, Giltinan DM.Nonlinear Models for Repeated Measures Data. New York: Chapman and Hall; 1995.

    Google Scholar 

  41. Verbeke G, Molenberghs G.Linear Mixed Models for Longitudinal Data. New York: Springer-Verlag, 2000.

    Google Scholar 

  42. US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry.Population Pharmacokinetics. Washington, DC: Food and Drug Administration; 1999.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Peter L. Bonate.

Additional information

Published: October 5, 2005

Rights and permissions

Reprints and permissions

About this article

Cite this article

Bonate, P.L. Recommended reading in population pharmacokinetic pharmacodynamics. AAPS J 7, 37 (2005). https://doi.org/10.1208/aapsj070237

Download citation

  • Received:

  • Accepted:

  • DOI: https://doi.org/10.1208/aapsj070237

Keywords

Navigation