A pragmatic approach to the design of population pharmacokinetic studies

AAPS Journal

Volumn 7, Issue 2, 2005, Pages

  Roy, Amit ^a   Ette, Ene I ^b  

^a BRISTOL MYERS SQUIBB   (United States)

^b VERTEX PHARMACEUTICALS   (United States)

Author keywords

D optimality; Informative block randomized design; Population Fisher information matrix D optimal design; Population pharmacokinetic sampling design

Indexed keywords

ENOXAPARIN;

ACCURACY; ARTICLE; COMPUTER PROGRAM; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG ELIMINATION; DRUG HALF LIFE; EXPERIMENTAL DESIGN; HUMAN; INTERMETHOD COMPARISON; PHARMACOLOGICAL PARAMETERS; POPULATION RESEARCH; PUBLICATION; SAMPLE SIZE; SIMULATION;

ANIMALS; COMPUTER SIMULATION; HUMANS; MODELS, THEORETICAL; PHARMACOKINETICS; RESEARCH DESIGN;

EID: 30544448391     PISSN: 15221059     EISSN: 15221059     Source Type: Journal    
DOI: 10.1208/aapsj070241     Document Type: Article

References (29)

1. Sheiner LB, Rosenberg B, Marathe VV. Estimation of population characteristics of population pharmacokinetic parameters from routine clinical data. J Pharmacokinet Biopharm. 1977;5:445-479.
2. Beal SL, Sheiner LB. Estimating population pharmacokinetics. Crit Rev Biomed Eng. 1982;8:195-222.
3. United States Food and Drug Administration. Guidance for Industry: Population Pharmacokinetics. Washington, DC: United States Food and Drug Administration; 1999.
4. Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters III. Monoexponential model: Clinical pharmacokinetic data. J Pharmacokinet Biopharm. 1983;11:303-319
5. al-Banna MK, Kelman AW, Whiting B. Experimental design and efficient parameter estimation in population pharmacokinetics. J Pharmacokinet Biopharm. 1990;18:347-360.
6. Hashimoto Y, Sheiner LB. Designs for population pharmacodynamics: Value of pharmacokinetic data and population analysis. J Pharmacokinet Biopharm. 1991;19:333-353.
7. Ette EI. Efficient parameter estimation in preclinical animal pharmacokinetics. PhD Thesis. University of Glasgow, Glasgow, Scotland, 1991.
8. Ette EI, Kelman AW, Howie CA, Whiting B. Efficient experimental design and estimation of population pharmacokinetic parameters in preclinical animal studies. Pharm Res. 1995;12:729-737.
9. Endrenyi L. Design of experiments for estimating enzyme and pharmacokinetic experiments. In: Endrenyi L, ed. Kinetic Data Analysis of Enzyme and Pharmacokinetic Experiments. New York: Plenum Press, 1981;137-167.
10. D'Argenio DZ. Optimal sampling times for pharmacokinetic experiments. J Pharmacokinet Biopharm. 1981;9:739-756.
11. Mori F, Di Stephano JJ III. Optimal nonuniform sampling interval and test-input design for identification of physiological systems from very limited data. IEEE Trans Auto Control. 1979;AC-24:893-900.
12. Landaw EM. Optimal design for individual parameter estimation in pharmacokinetics. In: Rowland M, Sheiner L, Steimer JL, eds. Variability in Drug Therapy: Description, Estimation, and Control. New York: Raven Press, 1985;187-200.
13. D'Argenio DZ, Shumitzky A. ADAPT II User's Guide: Pharmacokinetic/ Pharmacodynamic Systems Analysis Software. Los Angeles, CA: Biomedical Simulations Resource; 1997.
14. D'Argenio DZ. Incorporating prior parameter uncertainty in the design of sampling schedules for pharmacokinetic parameter estimation experiments. Math Biosci. 1990;99:105-118.
15. Tod M, Padoin C, Louchahi K, Moreau-Tod B, Petitjean O, Perret G. Implementation of OSPOP, an algorithm for the estimation of optimal sampling times by the ED, EID, and API criteria. Comp Method Prog Biomed. 1996;50:13-22.
16. Wang J, Endrenyi L. A computationally efficient approach for the design of population pharmacokinetic studies. J Pharmacokinet Biopharm. 1992;20:279-294.
17. Ette EI, Sun H, Ludden TM. Design of population pharmacokinetic studies. Proc Am Stat Assoc (Biopharmaceutics Section). 1994;487-492.
18. Fadiran EO, Jones CD, Ette EI. Designing population pharmacokinetic studies: Performance of mixed designs. Eur J Drug Metab Pharmacokinet. 2000;25:231-239.
19. Jonsson EN, Wade JR, Karlsson MO. Comparison of some practical sampling strategies for population pharmacokinetic studies. J Pharmacokinet Biopharm. 1996;24:245-263.
20. Sun H, Ette EI, Ludden TM. On the recording of sample times and parameter estimation from repeated measures of pharmacokinetic data. J Pharmacokinet Biopharm. 1996;24:637-650.
21. Mentre F, Mallet A, Baccar D. Optimal design in random-effects regression models. Biometrika. 1997;84:429-442.
22. Tod M, Mentre F, Merle Y, Mallet A. Robust optimal design for the estimation of hyperparameters in population pharmacokinetics. J Pharmacokinet Biopharm. 1998;26:689-716.
23. Retout S, Mentre F. Further developments of the Fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics. J Biopharm Stat. 2003;13:209-227.
24. Duffull SB, Retout S, Mentre F. The use of simulated annealing for finding optimal population designs. Comput Methods Programs Biomed. 2001;69:25-35.
25. Hooker AC, Foracchia M, Dobbs MG, Vicini P. An evaluation of population D-optimal designs via pharmacokinetic simulations. Ann Biomed Eng. 2003;31:98-111.
26. Retout S, Mentre F, Bruno R. Fisher information matrix for non-linear mixed-effects models: evaluation and application for optimal design of enoxaparin population pharmacokinetics. Stat Med. 2002;21:2623-2639.
27. Retout S, Mentre F. Optimization of individual and population designs using Splus. J Pharmacokinet Pharmacodyn. 2003;30:417-443.
28. Ette EI, Sun H, Ludden TM. Balanced designs in longditudinal population pharmacokinetic studies. J Clin Pharmacol. 1998;38:417-423.
29. Aarons L, Balant LP, Mentre F, et al. Practical experience and issues in designing and performing population pharmacokinetic/pharmacodynamic studies. Eur J Clin Pharmacol. 1996;49:251-254.