Prediction discrepancies for the evaluation of nonlinear mixed-effects models

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 33, Issue 3, 2006, Pages 345-367

  Mentré, France ^a,b,c   Escolano, Sylvie ^a  

^a INSERM   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

^c BICHAT HOSPITAL   (France)

Author keywords

Model evaluation; Population pharmacokinetics; Prediction errors; Predictive distribution

Indexed keywords

ARTICLE; KOLMOGOROV SMIRNOV TEST; MONTE CARLO METHOD; PRIORITY JOURNAL; SIMULATION; STATISTICAL MODEL;

ALGORITHMS; COMPUTER SIMULATION; LIKELIHOOD FUNCTIONS; MODELS, BIOLOGICAL; MODELS, STATISTICAL; MONTE CARLO METHOD; PHARMACOKINETICS; STATISTICAL DISTRIBUTIONS;

EID: 33745804100     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-005-0016-4     Document Type: Article

References (30)

1. L. B. Sheiner and J. L. Steimer. Pharmacokinetic/pharmacodynamic modeling in drug development. Annu. Rev. Pharmacol. Toxicol. 40:67-95 (2000).
2. L. Aarons, M. O. Karlsson, F. Mentré, F. Rombout, J. L. Steimer, A. van Peer, and Cost B15 experts. Role of modelling and simulation in phase I drug development. Eur. J. Pharm. Sci. 13:115-122 (2001).
3. N. H. Holford, H. C. Kimko, J. P. Monteleone, and C. C. Peck. Simulation of clinical trials. Annu. Rev. Pharmacol. Toxicol. 40:209-234 (2000).
4. L. J. Lesko, M. Rowland, C. C. Peck, and T. F. Blaschke. Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluations in humans. J. Clin. Pharmacol. 40:803-814 (2000).
5. H. C. Kimko and S. B. Duffull. Simulation for Designing Clinical Trials: A Pharmacokinetic - Pharmacodynamic Modeling Prospective. Marcel Dekker, New York, 2003.
6. Y. Yano, S. L. Beal, and L. B. Sheiner. Evaluating pharmacokinetic/ pharmacodynamic models using the posterior predictive check. J. Pharmacokinet. Pharmacodyn. 28:171-192 (2001).
7. M. Davidian and D. M. Giltinan. Nonlinear Models for Repeated Measurement Data. Chapman and Hall, London, 1995.
8. E. F. Vonesh and V. M. Chinchilli. Linear and Nonlinear Models for the Analysis of Repeated Measurements. Marcel Dekker, New York, 1997.
9. J. C. Pinheiro and D. M. Bates. Mixed-Effect Models in S and Splus. Springer Verlag, New York, 2000.
10. L. Aarons. Software for population pharmacokinetics and pharmacodynamics. Clin. Pharmacokinet. 36:255-264 (1999).
11. A. J. Boeckmann, L. B. Sheiner, and S. L. Beal. NONMEM users guide. NONMEM Users group at University of California, San Francisco, 1994.
12. F. Mentré and R. Gomeni. A two-step iterative algorithm for estimation in nonlinear mixed-effect models with an evaluation in population pharmacokinetics. J. Biopharm. Stat. 5:141-158 (1995).
13. R. D Wolfinger and X. Lin. Two Taylor-series approximation methods for estimation in nonlinear mixed-effects models with an evaluation in population pharmacokinetics. Comput. Stat. Data Anal. 25:465-490 (1997).
14. A. E. Gelfand. Model determination using sampling-based methods. Markov Chain Monte Carlo in Practice. Chapman & Hall, Boca Raton, 1996, pp. 145-161.
15. F. Mentré and M. E. Ebelin. Validation of population pharmacokinetic/pharmacodynamic analyses: review of proposed approaches. In The Population Approach: Measuring and Managing Variability in Response Concentration and Dose. Office for official publications of the European Communities, Brussels, 1997, pp. 141-158.
16. Food and Drug Administration. Guidance for Industry: Population Pharmacokinetics (available at http://www.fda.gov/cder/guidance/index.htm, 1999).
17. A. Gelman, J. B. Carlin, H. S. Stern, and D. B. Rubin. Bayesian Data Analysis. Chapman and Hall, London, 1995.
18. P. J. Williams and I. E. Ette. Determination of model appropriateness. In Simulation for Designing Clinical Trials: A Pharmacokinetic-Pharmacodynamic Modeling Prospective. Marcel Dekker, New York, 2003, pp. 73-104.
19. M. Evans. Comments of asymptotic distribution of P values in composite null models by J. M. Robins, A. van der Vaart and V. Ventura. J. Am. Stat. Assoc. 95:1160-1163 (2000).
20. M. J. Bayarri and J. O. Berger. P values for composite null models. J. Am. Stat. Assoc. 95:1127-1142 (2000).
21. J. M. Robins, A. van der Vaart, and V. Ventura. Asymptotic distribution of P values in composite null models (with discussion). J. Am. Stat. Assoc. 95:1143-1172 (2000).
22. N. Lange and L. Ryan. Assessing normality in random effects models. Ann. Statist. 17:624-642 (1989).
23. A. E. Gelfand, D. K. Det, and H. Chang. Model determination using predictive distributions with implementation via sampling-based methods. In Bayesian Statistics 4. University Press, Oxford, 1992, pp. 147-167.
24. N. G. Best, K. K. C. Tan, W. R. Gilks, and D. J. Spiegelhalter. Estimation of Population Pharmacokinetics using the Gibbs sampler. J. Pharmacokinet. Biopharm. 23:407-435 (1995).
25. F. Mesnil, F. Mentré, C. Dubruc, J. P. Thénot, and A. Mallet. Population pharmacokinetic analysis of mizolastine and validation from sparse data on patients using the nonparametric maximum likelihood method. J. Pharmacokinet. Biopharm. 26:133-161 (1998).
26. A. Mallet. A maximum likelihood estimation method for random coefficient regression models. Biometrika 73:645-646 (1996).
27. E. Comets, K. Ikeda, P. Hoff, P. Fumoleau, J. Wanders, and Y. Tanigawara. Comparison of the pharmacokinetics of S-1, an oral anticancer agent, in Western and Japanese patients. J. Pharmacokinet. Pharmacodyn. 30:257-283 (2003).
28. A. Gelman and X.L. Meng. Model checking and model improvement. In Markov Chain Monte Carlo in Practice. Chapman & Hall, Boca Raton, 1996, pp. 189-201.
29. R. B. D'Agostino and M.A. Stephens. Goodness-of-Fit Techniques. Marcel Dekker, New York, 1986.
30. P. McCullagh and J. A. Nelder. Generalized Linear Models. Chapman & Hall, London, 1989.