Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0

Computer Methods and Programs in Biomedicine

Volumn 98, Issue 1, 2010, Pages 55-65

  Bazzoli, Caroline ^a,b   Retout, Sylvie ^a,b   Mentré, France ^a,b  

^a INSERM   (France)

^b UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

D optimality; Fisher information matrix; Multiple response models; Nonlinear mixed effect models; Optimal designs; PFIM

Indexed keywords

COMPLEX MODEL; D-OPTIMAL DESIGNS; D-OPTIMALITY; DESIGN EVALUATION; EXTENDED VERSIONS; JOINT ANALYSIS; LINEARISATION; MODEL SPECIFICATIONS; MULTIPLE RESPONSE; NONLINEAR MIXED EFFECTS; OPTIMAL DESIGN; OPTIMISATIONS; PHARMACOKINETICS MODELS; R-FUNCTIONS; REAL EXAMPLE; RESPONSE MODEL; SIMPLEX ALGORITHM;

ALGORITHMS; DESIGN; DRUG PRODUCTS; OPTIMAL SYSTEMS; OPTIMIZATION; ORDINARY DIFFERENTIAL EQUATIONS; PHARMACOKINETICS;

FISHER INFORMATION MATRIX;

WARFARIN;

ALGORITHM; ANTICOAGULATION; ARTICLE; COMPUTER INPUT DEVICE; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG ELIMINATION; DRUG RESPONSE; EVALUATION; HUMAN; HUMAN EXPERIMENT; MATHEMATICAL ANALYSIS; MATHEMATICAL MODEL; NORMAL HUMAN; PROCESS DESIGN; PROCESS OPTIMIZATION; SINGLE DRUG DOSE;

ALGORITHMS; ANTICOAGULANTS; COMPUTER SIMULATION; HUMANS; MODELS, STATISTICAL; NONLINEAR DYNAMICS; RESEARCH DESIGN; SOFTWARE; WARFARIN;

EID: 77950369264     PISSN: 01692607     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cmpb.2009.09.012     Document Type: Article

References (33)

1. Sheiner L., Wakefield J. Population modelling in drug development. Stat. Methods Med. Res. 1999, 8:183-193.
2. Pillai G.C., Mentré F., Steimer J.L. Non-linear mixed effects modelling-from methodology and software development to driving implementation in drug development science. J. Pharmacokinet. Pharmacodyn. 2005, 32:161-183.
3. Atkinson AC., Donev A.N. Optimum Experimental Designs 1992, Clarendon Press, Oxford.
4. Walter E., Pronzato L. Identification of Parametric Models from experimental Data 1997, Springer, New York.
5. Mentré F., Mallet A., Baccar D. Optimal design in random effect regression models. Biometrika 1997, 84:429-442.
6. Retout S., Mentré 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.
7. Retout S., Mentré F. Optimization of individual and population designs using Splus. J. Pharmacokinet. Pharmacodyn. 2003, 30:417-443.
8. Retout S., Mentré 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.
9. Green B., Duffull S.B. Prospective evaluation of a D-optimal designed population pharmacokinetic study. J. Pharmacokinet. Pharmacodyn. 2003, 30:145-161.
10. Mentré F., Dubruc C., Thenot J.P. Population pharmacokinetic analysis and optimization of the experimental design for mizolastine solution in children. J. Pharmacokinet. Pharmacodyn. 2001, 28:299-319.
11. Retout S., Duffull S., Mentré F. Development and implementation of the population Fisher information matrix for the evaluation of population pharmacokinetic designs. Comput. Methods Programs Biomed. 2001, 65:141-151.
12. Retout S., Comets E., Bazzoli C., Mentré F. Design optimisation in nonlinear mixed effects models using cost functions: application to a joint model of infliximab and methotrexate pharmacokinetics. Commun. Stat. A-Theor. 2009, 38:3351-3368.
13. Nelder J.A., Mead R. A Simplex method for function minimization. Comput. J. 1965, 1:308-313.
14. Bazzoli C., Retout S., Mentre F. Fisher information matrix for nonlinear mixed effects multiple response models: evaluation of the appropriateness of the first order linearization using a pharmacokinetic/pharmacodynamic model. Stat. Med. 2009, 28:1940-1956.
15. Gueorguieva I., Aarons L., Ogungbenro K., Jorga K.M., Rodgers T., Rowland M. Optimal design for multivariate response pharmacokinetic models. J. Pharmacokinet. Pharmacodyn. 2006, 33:97-124.
16. Hooker A., Vicini P. Simultaneous population optimal design for pharmacokinetic-pharmacodynamic experiments. AAPS J. 2005, 7:E759-785.
17. Lavielle M. MONOLIX (MOdèles NOn LInéaires à effets miXtes) 2005, MONOLIX Group, Orsay, France.
18. Retout S., Comets E., Samson A., Mentré F. Design in nonlinear mixed effects models: optimization using the Fedorov-Wynn algorithm and power of the Wald test for binary covariates. Stat. Med. 2007, 26:5162-5179.
19. R Development Core Team R: A Language and Environment for Statistical Computing 2004, R Foundation for Statistical Computing, Vienna, Austria.
20. Lindstrom M.L., Bates D.M. Nonlinear mixed effects models for repeated measures data. Biometrics 1990, 46:673-687.
21. J. Pinheiro, D.M. Bates, Mixed-Effects Models in S and Splus, New York, NY, 2000.
22. Hindmarsh A.C. ODEPACK, A systematized collection of ODE solvers. Scientific Computing: Applications of Mathematics and Computing to the Physical Sciences 1983, 55-64. Elsevier Science Ltd, Amsterdam. R.S. Stepleman (Ed.).
23. Petzold L.R. Automatic selection of methods for solving stiff and nonstiff systems of ordinary differential equations. Siam J. Sci. Stat. Comput. 1983, 4:136-148.
24. Fedorov V.V. Theory of Optimal Experiments 1972, Academic Press, New York.
25. Wynn H.P. Results in the construction of D-optimum experimental designs. J. R. Statist. Soc. 1972, 34:133-147.
26. O'Reilly R.A., Aggeler P.M. Studies on coumarin anticoagulant drugs. Initiation of warfarin therapy without a loading dose. Circulation 1968, 38:169-177.
27. O'Reilly R.A., Aggeler P.M., Leong L.S. Studies on the coumarin anticoagulant drugs: the pharmacodynamics of warfarin in man. J. Clin. Invest. 1963, 42:1542-1551.
28. Holford N.H. Clinical pharmacokinetics and pharmacodynamics of warfarin. Understanding the dose-effect relationship. Clin. Pharmacokinet. 1986, 11:483-504.
29. Retout S., Bazzoli C., Comets E., Le Nagard H., Mentré F. Population designs evaluation and optimisation in R: the PFIM function and its new features. 16th Meeting of Population Group Approach in Europe (PAGE) 2007, Abstr. 1164. http://www.page-meeting.org/?abstract=1164.
30. Beal S.L., Sheiner L.B. NONMEM Users Guide 1992, University of California, San Francisco.
31. Bazzoli C., Retout S., Rey E., Benech H., Tréluyer J.M., Salmon D., Duval X., Mentré F., COPHAR2-ANRS 111 study group Population pharmacokinetic of AZT and its active metabolite AZT-TP in HIV patients (COPHAR 2-ANRS 111 trial): joint modelling and design optimisation. 17th Meeting of Population Group Approach in Europe (PAGE) 2008, Abstr. 1373. http://www.page-meeting.org/?abstract=1373.
32. Mentré F., Duffull S., Gueorguieva I., Hooker A., Leonov S., Ogungbenro K., Retout S. Software for Optimal Design in Population Pharmacokinetics and Pharmacodynamics: A Comparison 2007, Population Approach Group in Europe (PAGE), Copenhagen, Denmark.
33. Ogungbenro K., Graham G., Gueorguieva I., Aarons L. Incorporating correlation in interindividual variability for the optimal design of multiresponse pharmacokinetic experiments. J. Biopharm. Stat. 2008, 18:342-358.