Conditional Weighted Residuals (CWRES): A Model Diagnostic for the FOCE Method

Springer Science and Business Media LLC - Tập 24 Số 12 - Trang 2187-2197 - 2007
Andrew C. Hooker1, Christine E. Staatz1, Mats O. Karlsson1
1Division of Pharmacokinetics and Drug Therapy, Department of Pharmaceutical Biosciences, Faculty of Pharmacy, Uppsala University, Uppsala, Sweden

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L. Zhang, V. Sinha, S. T. Forgue, S. Callies, L. Ni, R. Peck, and S. R. Allerheiligen. Model-based drug development: the road to quantitative pharmacology. J. Pharmacokinet. Pharmacodyn. 33:369–393 (2006).

L. Aarons, M. O. Karlsson, F. Mentre, F. Rombout, J. L. Steimer, A. van Peer. Role of modelling and simulation in Phase I drug development. Eur. J. Pharm. Sci. 13:115–122 (2001).

J. C. Pinheiro, M. J. Lindstrom. Model building for nonlinear mixed effects models, (1994).

A. T. Galecki, R. D. Wolfinger, O. A. Linares, M. J. Smith, and J. B. Halter. Ordinary differential equation PK/PD models using the SAS macro NLINMIX. J. Biopharm. Stat. 14:483–503 (2004).

P. Girard and F. Mentré. A comparison of estimation methods in nonlinear mixed effects models using a blind analysis, PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe, Vol. 14, Abstr 834 [ http://www.page-meeting.org/?abstract=834 ], Pamplona, Spain, 2005.

S. Beal and L. Sheiner. The NONMEM system. Am. Stat. 34:118–119 (1980).

U. Wahlby, E. N., and Jonsson, M. O. Karlsson. Assessment of actual significance levels for covariate effects in NONMEM. J. Pharmacokinet. Pharmacodyn. 28:231–252 (2001).

E. N. Jonsson, J. R. Wade, and M. O. Karlsson. Comparison of some practical sampling strategies for population pharmacokinetic studies. J. Pharmacokinet. Biopharm. 24:245–263 (1996).

B. P. Booth and J. V. Gobburu. Considerations in analyzing single-trough concentrations using mixed-effects modeling. J. Clin. Pharmacol. 43:1307–1315 (2003).

S. Beal and L. Sheiner. NONMEM User’s Guide, University of California, San Francisco, 1992.

Guidance for industry on Population Pharmacokinetics; availability. Food and Drug Administration, HHS. Notice. Fed Regist. 64:6663–6664 (1999).

M. Davidian and D. M. Giltinan. Nonlinear models for repeated measurement data, Chapman & Hall, New York, 1995.

M. L. Lindstrom and D. M. Bates. Nonlinear mixed effects models for repeated measures data. Biometrics. 46:673–687 (1990).

F. Mentre and S. Escolano. Prediction discrepancies for the evaluation of nonlinear mixed-effects models. J. Pharmacokinet. Pharmacodyn. 33:345–367 (2006).

E. N. Jonsson and M. O. Karlsson. Xpose—an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM. Comput. Methods Programs Biomed. 58:51–64 (1999).

L. Lindbom, P. Philgren, and N. Jonsson. PsN-Toolkit—a collection of computer intensive statistical methods for non-linear mixed effect modelling using NONMEM. Comput. Methods Programs Biomed. 79:241–257 (2005).

M. Abramowitz and I. A. Stegun. Handbook of mathematical functions with formulas, graphs, and mathematical tables, 9th printing, Dover, New York, 1972.

J. E. Bennett and J. C. Wakefield. A comparison of a Bayesian population method with two methods as implemented in commercially available software. J. Pharmacokinet. Biopharm. 24:403–432 (1996).

M. O. Karlsson, E. N. Jonsson, C. G. Wiltse, and J. R. Wade. Assumption testing in population pharmacokinetic models: illustrated with an analysis of moxonidine data from congestive heart failure patients. J. Pharmacokinet. Biopharm. 26:207–246 (1998).

R. Savic, D. M. Jonker, T. Kerbusch, and M. O. Karlsson. Evaluation of a transit compartment model versus a lag time model for describing drug absorption delay, PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe, Vol. 13, Abstr 513 [ http://www.page-meeting.org/?abstract=513 ], Uppsala, Sweden, 2004.

A. Hooker, A. J. T. Tije, M. A. Carducci, H. Gelderblom, F. W. Dawkins, W. P. McGuire, J. Verweij, M. O. Karlsson, and S. D. Baker. Population pharmacokinetic modeling of total and unbound docetaxel plasma concentrations in cancer patients with poor liver function, PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe, Vol. 14, Abstr 815 [ http://www.page-meeting.org/?abstract=815 ], Pamplona, Spain, 2005.

A. Quartino, M. O. Karlsson, A. Freijs, N. Jonsson, P. Nygren, J. Kristensen, E. Lindhagen, and R. Larsson. Population Based Pharmacodynamics for In Vitro Drug Sensitivity Assays: Prediction of Model Based Parameters of Drug Activity and Relationship to Clinical Outcome, PAGE Abstracts of the Annual Meeting of the Population Approach Group in Europe, Vol. 14, Abstr 809 [ http://www.page-meeting.org/?abstract=809 ], Pamplona, Spain, 2005.