Open AccessEstablishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development
Author(s) -
Overgaard RV,
Ingwersen SH,
Tornøe CW
Publication year - 2015
Publication title -
cpt: pharmacometrics and systems pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 37
ISSN - 2163-8306
DOI - 10.1002/psp4.12015
Subject(s) - drug development , drug response , key (lock) , drug , process (computing) , medicine , process management , computer science , psychology , pharmacology , engineering , computer security , operating system
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.