Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models

AAPS Journal

Volumn 13, Issue 2, 2011, Pages 143-151

  Bergstrand, Martin ^a   Hooker, Andrew C ^a   Wallin, Johan E ^a,b   Karlsson, Mats O ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b ELI LILLY AND COMPANY   (United States)

Author keywords

mixed effects modeling; model diagnostics; pcVPC; prediction correction; VPC

Indexed keywords

MOXONIDINE; TACROLIMUS;

ANALYTICAL ERROR; ARTICLE; COMPUTER PROGRAM; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG MONITORING; HUMAN; INFUSION RATE; INTERMETHOD COMPARISON; NONLINEAR SYSTEM; POPULATION MODEL; PREDICTION; SIMULATION; STATISTICAL MODEL; VISUAL PREDICTIVE CHECK;

COMPUTER SIMULATION; DRUG MONITORING; HUMANS; MODELS, BIOLOGICAL; NONLINEAR DYNAMICS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS;

EID: 79957451960     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9255-z     Document Type: Article

References (27)

1. J Orloff F Douglas J Pinheiro S Levinson M Branson P Chaturvedi, et al. 2009 The future of drug development: advancing clinical trial design Nat Rev Drug Discov 8 12 949 957 19816458 1:CAS:528:DC%2BD1MXht1CisLnJ
2. MO Karlsson RM Savic 2007 Diagnosing model diagnostics Clin Pharmacol Ther 82 1 17 20 17571070 10.1038/sj.clpt.6100241 1:STN:280: DC%2BD2szlvVakug%3D%3D (Pubitemid 46944205)
3. LB Sheiner SL Beal A Dunne 1997 Analysis of nonrandomly censored ordered categorical longitudinal data from analgesic trials J Am Stat Assoc 92 440 1235 1244 10.2307/2965391
4. Holford N. The visual predictive check-superiority to standard diagnostic (Rorschach) plots. PAGE 14 (2005) Abstr 738 [ www.page-meeting.org/?abstract= 738 ].
5. Karlsson MO, Holford N. A tutorial on visual predictive checks. PAGE 17 (2008) Abstr 1434 [ www.page-meeting.org/?abstract=1434 ].
6. TM Post JI Freijer BA Ploeger M Danhof 2008 Extensions to the visual predictive check to facilitate model performance evaluation J Pharmacokinet Pharmacodyn 35 2 185 202 18197467 10.1007/s10928-007-9081-1
7. Wang DD, Zhang S. Standardized visual predictive check-how and when to used it in model evaluation. PAGE 18 (2009) Abstr 1501 [ www.page-meeting.org/? abstract=1501 ].
8. Wallin JE, Friberg LE, Fasth A, Staatz CE. Population pharmacokinetics of tacrolimus in pediatric hematopoietic stem cell transplant recipients: new initial dosage suggestions and a model-based dosage adjustment tool. Ther Drug Monit. 2009 Jun 11.
9. Gibiansky L. Parameter estimates of population models: comparison of nonmem versions and estimation methods. PAGE 17 (2008) Abstr 1268 [ www.page-meeting.org/?abstract=1268 ].
10. L Brynne JL McNay HG Schaefer K Swedberg CG Wiltse MO Karlsson 2001 Pharmacodynamic models for the cardiovascular effects of moxonidine in patients with congestive heart failure Br J Clin Pharmacol 51 1 35 43 11167663 10.1046/j.1365-2125.2001.01320.x 1:CAS:528:DC%2BD3MXhtF2hu74%3D (Pubitemid 32118818)
11. Beal SL, Sheiner LB, Boeckmann AJ. NONMEM user's guides. Ellicot City: MD: Icon Development Solutions; 1989-2006.
12. L Lindbom P Pihlgren EN Jonsson 2005 PsN-Toolkit-a collection of computer intensive statistical methods for non-linear mixed effect modeling using NONMEM Comput Method Programs Biomed 79 3 241 257 10.1016/j.cmpb.2005.04.005 (Pubitemid 41196689)
13. L Lindbom J Ribbing EN Jonsson 2004 Perl-speaks-NONMEM (PsN)-a Perl module for NONMEM related programming Comput Method Programs Biomed 75 2 85 94 10.1016/j.cmpb.2003.11.003 (Pubitemid 38798039)
14. Harling K, Ueckert S, Hooker AC, Jonsson EN, Karlsson MO. Xpose and Perl speaks NONMEM (PsN). PAGE 19 (2010) Abstr 1842 [ www.page-meeting.org/?abstract= 1842 ].
15. EN Jonsson MO Karlsson 1999 Xpose-an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM Comput Method Programs Biomed 58 1 51 64 10.1016/S0169-2607(98)00067-4 1:STN:280: DyaK1M3htVShsw%3D%3D (Pubitemid 29049052)
16. R: a language and environment for statistical computing. R Foundation for Statistical Computing; 2009 [2009-12-30]; Available from: http://www.R-project. org.
17. Box GEP, Draper NR. Empirical model-building and response surfaces: Wiley; 1987.
18. Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction corrected visual predictive checks. ACoP (2009) Abstr F7 http://2009.go-acop.org/sites/ all/assets/webform/Poster-ACoP-VPC-091002-two-page.pdf.
19. Ma G, Olsson BL, Rosenborg J, Karlsson MO. Quantifying lung function progression in asthma. PAGE 18 (2009) Abstr 1562 [ www.page-meeting.org/? abstract=1562 ].
20. C Dansirikul HE Silber MO Karlsson 2008 Approaches to handling pharmacodynamic baseline responses J Pharmacokinet Pharmacodyn 35 3 269 283 18446428 10.1007/s10928-008-9088-2 1:CAS:528:DC%2BD1cXosVGiu74%3D
21. M Bergstrand MO Karlsson 2009 Handling data below the limit of quantification in mixed effect models AAPS J 11 2 371 380 19452283 10.1208/s12248-009-9112-5 1:CAS:528:DC%2BD1MXhtVWqs7vJ
22. LE Friberg R de Greef T Kerbusch MO Karlsson 2009 Modeling and simulation of the time course of asenapine exposure response and dropout patterns in acute schizophrenia Clin Pharmacol Ther 86 1 84 91 19387434 10.1038/clpt.2009.44 1:CAS:528:DC%2BD1MXnsFemtbo%3D
23. E Kuhn M Lavielle 2005 Maximum likelihood estimation in nonlinear mixed effects models Comput Stat Data Anal 49 4 1020 1038 10.1016/j.csda.2004.07.002 (Pubitemid 40710158)
24. Khachman D, Laffont CM, Concordet D. You have problems to interpret VPC? Try VIPER! PAGE 19 (2010) Abstr 1892 [ www.page-meeting.org/?abstract=1892 ].
25. Laffont CM, Concordet D. A new exact test to globally assess a population PK and/or PD model. PAGE 18 (2009) Abstr 1633 [ www.page-meeting.org/?abstract= 1633 ].
26. E Comets K Brendel F Mentré 2008 Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R Comput Meth Programs Biomed 90 2 154 166 10.1016/j.cmpb.2007.12. 002
27. E Comets K Brendel F Mentré 2010 Model evaluation in nonlinear mixed effect models, with applications to pharmacokinetics J Soc Fr Stat 151 1 106 128