Optimal design for population pk/pd models

Leonov, Sergei; Aliev, Alexander

doi:10.2478/v10127-012-0012-1

Abstract

We provide some details of the implementation of optimal design algorithm in the PkStaMp library which is intended for constructing optimal sampling schemes for pharmacokinetic (PK) and pharmacodynamic (PD) studies. We discuss different types of approximation of individual Fisher information matrix and describe a user-defined option of the library.

References

[1] ALIEV, A.-FEDOROV, V.-LEONOV, S.-MCHUGH, B.: PkStaMp library for opti- mization of sampling schemes for PK/PD models, in: Proc. of the 6th St. Petersburg Workshop on Simulation, Vol. 1 (S. M. Ermakov et al., eds.), VVM com Ltd., St. Petersburg, Russia, 2009, pp. 368-374.
Search in Google Scholar
[2] ALIEV, A.-FEDOROV, V.-LEONOV, S.-MCHUGH, B.-MAGEE, M.: PkStaMp library for constructing optimal population designs for PK/PD studies, Commun. Stat., Simulation Comput. 41 (2012), 717-729.
Search in Google Scholar
[3] ATKINSON, A. C.-DONEV, A.: Optimum Experimental Design. Clarendon Press, Oxford, 1992.
Search in Google Scholar
[4] ATWOOD, C. L.: Sequences converging to D-optimal designs of experiments, Ann. Stat. 1 (1973), 342-352.10.1214/aos/1176342371
Search in Google Scholar
[5] BATES, D. M.-WATTS, D. G.: Nonlinear Regression Analysis and its Applications. Wiley, New York, 1988.10.1002/9780470316757
Search in Google Scholar
[6] BAZZOLI, C.-RETOUT, S.-MENTR´ E, 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. 28 (2009), 1940-1956.10.1002/sim.357319266541
Search in Google Scholar
[7] DUFFULL, S. B.-WATERHOUSE, T. H.-ECCLESTON, J. A.: Some considerations on the design of population pharmacokinetic studies, J. Pharmacokin. Pharmacodyn. 32 (2005), 441-457.10.1007/s10928-005-0034-216284917
Search in Google Scholar
[8] FEDOROV, V. V.: Theory of Optimal Experiment. Academic Press, New York, 1972.
Search in Google Scholar
[9] FEDOROV, V. V.-GAGNON, R.-LEONOV, S.-WU, Y.: Optimal design of experi- ments in pharmaceutical applications, in: Pharmaceutical Statistics Using SAS. A Practical Guide (A. Dmitrienko et al., eds.), SAS Press, Cary, NC, 2007, 151-195.
Search in Google Scholar
[10] FEDOROV, V. V.-HACKL, P.: Model-Oriented Design of Experiments. Springer, New York, 1997.10.1007/978-1-4612-0703-0
Search in Google Scholar
[11] FEDOROV, V. V.-LEONOV, S.: Response driven designs in drug development, in: Applied Optimal Designs (W. K. Wong and M. P. F. Berger, eds.), Wiley, Chichester, 2005, pp. 103-136.10.1002/0470857005.ch5
Search in Google Scholar
[12] GAGNON, R.-LEONOV, S.: Optimal population designs for PK models with serial sampling, J. Biopharm. Statist. 15 (2005), 143-163.10.1081/BIP-20004085315702610
Search in Google Scholar
[13] GUEORGUIEVA, I.-OGUNGBENRO,K.-GRAHAM,G.-GLATT, S.-AARONS, L.: A program for individual and population optimal design for univariate and multivari- ate response pharmacokinetic-pharmacodynamic models, Comput. Methods Programs Biomed. 86 (2007), 51-61.10.1016/j.cmpb.2007.01.00417292995
Search in Google Scholar
[14] MAGNUS, J. R.-NEUDECKER, H.: Matrix Differential Calculus with Applications in Statistics and Econometrics. Wiley, New York, 1988.10.2307/2531754
Search in Google Scholar
[15] MENTR´ E, F.-NYBERG, J.-OGUNGBENRO, K.-LEONOV, S.-ALIEV, A.-DUFFULL, S.-BAZZOLI, C.-HOOKER, A.: Comparison of results of the different software for design evaluation in population pharmacokinetics and pharmacodynamics, in: Abstracts of the Annual Meeting of the Population Approach Group in Europe (PAGE), 2011, http://www.page-meeting.org/default.asp?abstract=2066.
Search in Google Scholar
[16] MERL´ E, Y.-TODD, M.: Impact of pharmacokineticpharmacodynamic model lineariza- tion on the accuracy of population information matrix and optimal design, J. Pharmacokin. Pharmacodyn. 28 (2001), 363-388.10.1023/A:1011534830530
Search in Google Scholar
[17] MIELKE, T.-SCHWABE, R.: Some considerations on the Fisher information in nonlin- ear mixed effects models, in: mODa 9-Advances in Model-Oriented Design and Analysis (A. Giovagnoli et al., eds.), Physica-Verlag/Springer, Berlin, 2010, pp. 129-136.10.1007/978-3-7908-2410-0_17
Search in Google Scholar
[18] MONOLIX: http://www.lixoft.net/monolix/overview/, Lixoft, 2011.
Search in Google Scholar
[19] NEUMANN, A. U.-LAM, N. P.-DAHARI, H.-GRETCH, D. R.-WILEY, T. E.- -LAYDEN, T. J.-PERELSON, A. S.: Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-_ therapy, Science 282 (1998), 103-107.10.1126/science.282.5386.1039756471
Search in Google Scholar
[20] NYBERG, J.-UECKERT, S.-STR¨OMBERG, E.-KARLSSON, M. O.-HOOKER, A. C.: PopED, version 2.12, 2011, http://poped.sourceforge.net.
Search in Google Scholar
[21] P´AZMAN, A.: Nonlinear Statistical Models. Kluwer Academic Publshers, Dordrecht, 1993.
Search in Google Scholar
[22] RATKOWSKY, D. A.: Nonlinear Regression Modeling. Marcel Dekker, New York, 1983.
Search in Google Scholar
[23] RETOUT, S.-MENTR´ E, F.: Further developments of the Fisher information matrix in nonlinear mixed effects models with evaluation in population pharmacokinetics, J. Biopharm. Statist. 13 (2003), 209-227.10.1081/BIP-12001926712729390
Search in Google Scholar
[24] WYNN, H. P.: The sequential generation of D-optimal experimental designs, Ann. Math. Statist. 41 (1970), 1655-1664.10.1214/aoms/1177696809
Search in Google Scholar

Optimal design for population pk/pd models

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