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


ABSTRACT: 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.

SUBMITTER: Overgaard RV 

PROVIDER: S-EPMC4625861 | biostudies-other | 2015 Oct

REPOSITORIES: biostudies-other

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

Overgaard R V RV   Ingwersen S H SH   Tornøe C W CW  

CPT: pharmacometrics & systems pharmacology 20150922 10


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  ...[more]

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