Overview of model-building strategies in population PK/PD analyses: 2002-2004 literature survey. - Inserm - Institut national de la santé et de la recherche médicale Accéder directement au contenu
Article Dans Une Revue British Journal of Clinical Pharmacology Année : 2007

Overview of model-building strategies in population PK/PD analyses: 2002-2004 literature survey.

Résumé

AIMS: A descriptive survey of published population pharmacokinetic and/or pharmacodynamic (PK/PD) analyses from 2002 to 2004 was conducted and an evaluation made of how model building was performed and reported. METHODS: We selected 324 articles in Pubmed using defined keywords. A data abstraction form (DAF) was then built comprising two parts: general characteristics including article identification, context of the analysis, description of clinical studies from which the data arose, and model building, including description of the processes of modelling. The papers were examined by two readers, who extracted the relevant information and transmitted it directly to a MySQL database, from which descriptive statistical analysis was performed. RESULTS: Most published papers concerned patients with severe pathology and therapeutic classes suffering from narrow therapeutic index and/or high PK/PD variability. Most of the time, modelling was performed for descriptive purposes, with rich rather than sparse data and using NONMEM software. PK and PD models were rarely complex (one or two compartments for PK; E(max) for PD models). Covariate testing was frequently performed and essentially based on the likelihood ratio test. Based on a minimal list of items that should systematically be found in a population PK-PD analysis, it was found that only 39% and 8.5% of the PK and PD analyses, respectively, published from 2002 to 2004 provided sufficient detail to support the model-building methodology. CONCLUSIONS: This survey allowed an efficient description of recent published population analyses, but also revealed deficiencies in reporting information on model building.
Fichier principal
Vignette du fichier
DAFGeneralCharacteristics.pdf (122.25 Ko) Télécharger le fichier
DARTOIS_BJCP_final.pdf (294.22 Ko) Télécharger le fichier
Dartois_DAFModelBuilding_BJCP.pdf (156.06 Ko) Télécharger le fichier
Origine : Fichiers produits par l'(les) auteur(s)
Origine : Fichiers produits par l'(les) auteur(s)
Origine : Fichiers produits par l'(les) auteur(s)

Dates et versions

inserm-00159122 , version 1 (14-09-2009)

Identifiants

Citer

Céline Dartois, Karl Brendel, Emmanuelle Comets, Céline M. Laffont, Christian Laveille, et al.. Overview of model-building strategies in population PK/PD analyses: 2002-2004 literature survey.. British Journal of Clinical Pharmacology, 2007, 64 (5), pp.603-12. ⟨10.1111/j.1365-2125.2007.02975.x⟩. ⟨inserm-00159122⟩
127 Consultations
580 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More