Influence of covariance between random effects in design for nonlinear mixed-effect models with an illustration in pediatric pharmacokinetics.

Cyrielle Dumont 1, 2, * Marylore Chenel 1 France Mentré 2
* Auteur correspondant
1 IRIS - Institut de Recherches Internationales Servier
2 Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques
Abstract : Nonlinear mixed-effect models are used increasingly during drug development. For design, an alternative to simulations is based on the Fisher information matrix. Its expression was derived using a first-order approach, was then extended to include covariance and implemented into the R function PFIM. The impact of covariance on standard errors, amount of information, and optimal designs was studied. It was also shown how standard errors can be predicted analytically within the framework of rich individual data without the model. The results were illustrated by applying this extension to the design of a pharmacokinetic study of a drug in pediatric development.
Keywords : D-optimality Fisher information matrix Nonlinear mixed e ect models Opti- mal design Paediatric studies PFIM Population pharmacokinetics
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Article dans une revue
Journal of Biopharmaceutical Statistics, Taylor & Francis, 2014, 24 (3), pp.471-92. 〈10.1080/10543406.2014.888443〉
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Cyrielle Dumont, Marylore Chenel, France Mentré. Influence of covariance between random effects in design for nonlinear mixed-effect models with an illustration in pediatric pharmacokinetics.. Journal of Biopharmaceutical Statistics, Taylor & Francis, 2014, 24 (3), pp.471-92. 〈10.1080/10543406.2014.888443〉. 〈inserm-00769812〉

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