Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development

This tutorial aims at promoting good practices for exposure–response (E-R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E-R analyses to assist modeling scientists with a process of performing such analyses in a consistent manner across individuals and proj...

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Detalles Bibliográficos
Autores principales: Overgaard, RV, Ingwersen, SH, Tornøe, CW
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Ltd 2015
Materias:
Tutorial
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4625861/
https://www.ncbi.nlm.nih.gov/pubmed/26535157
http://dx.doi.org/10.1002/psp4.12015
Descripción
Sumario:This tutorial aims at promoting good practices for exposure–response (E-R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E-R analyses to assist modeling scientists with a process of performing such analyses in a consistent manner across individuals and projects and tailored to typical clinical drug development decisions. This includes general considerations for planning, conducting, and visualizing E-R analyses, and how these are linked to key questions.

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