1. Prior information for population pharmacokinetic and pharmacokinetic/pharmacodynamic analysis: overview and guidance with a focus on the NONMEM PRIOR subroutine
- Author
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David Fabre, Sonia Khier, Anna H.-X. P. Chan Kwong, Elisa A. M. Calvier, Florence Gattacceca, Université de Montpellier (UM), Institut Montpelliérain Alexander Grothendieck (IMAG), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Sanofi-Aventis R&D, SANOFI Recherche, Laboratoire de pharmacocinétique [Montpellier] (Faculté de Pharmacie - UM1), and Université Montpellier 1 (UM1)
- Subjects
Computer science ,Subroutine ,Population ,Datasets as Topic ,Pharmacokinetic-pharmacodynamic ,computer.software_genre ,030226 pharmacology & pharmacy ,Models, Biological ,03 medical and health sciences ,0302 clinical medicine ,[SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication ,Covariate ,Humans ,Computer Simulation ,Sensitivity (control systems) ,Population pharmacokinetics ,education ,Reference model ,NONMEM ,Pharmacology ,0303 health sciences ,education.field_of_study ,[STAT.AP]Statistics [stat]/Applications [stat.AP] ,Review Paper ,030306 microbiology ,Bayes Theorem ,[SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences ,Markov Chains ,Biological Variation, Population ,Pharmacology, Clinical ,Practice Guidelines as Topic ,A priori and a posteriori ,Guidance ,Data mining ,PRIOR ,Focus (optics) ,computer ,Software ,Model - Abstract
Population pharmacokinetic analysis is used to estimate pharmacokinetic parameters and their variability from concentration data. Due to data sparseness issues, available datasets often do not allow the estimation of all parameters of the suitable model. The PRIOR subroutine in NONMEM supports the estimation of some or all parameters with values from previous models, as an alternative to fixing them or adding data to the dataset. From a literature review, the best practices were compiled to provide a practical guidance for the use of the PRIOR subroutine in NONMEM. Thirty-three articles reported the use of the PRIOR subroutine in NONMEM, mostly in special populations. This approach allowed fast, stable and satisfying modelling. The guidance provides general advice on how to select the most appropriate reference model when there are several previous models available, and to implement and weight the selected parameter values in the PRIOR function. On the model built with PRIOR, the similarity of estimates with the ones of the reference model and the sensitivity of the model to the PRIOR values should be checked. Covariates could be implemented a priori (from the reference model) or a posteriori, only on parameters estimated without prior (search for new covariates). Graphic abstract Electronic supplementary material The online version of this article (10.1007/s10928-020-09695-z) contains supplementary material, which is available to authorized users.
- Published
- 2020