Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development
Authors:
Open Access
- 18 July 2015
- journal article
- tutorial
- Published by Wiley in CPT: Pharmacometrics & Systems Pharmacology
- Vol. 4 (10) , 565-575
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.Keywords
This publication has 22 references indexed in Scilit:
- Performance of Nonlinear Mixed Effects Models in the Presence of Informative DropoutThe AAPS Journal, 2014
- A Time to Event Tutorial for PharmacometriciansCPT: Pharmacometrics & Systems Pharmacology, 2013
- The Combination of Exposure‐Response and Case‐Control Analyses in Regulatory Decision MakingThe Journal of Clinical Pharmacology, 2013
- Exposure–Response modeling of anti-depressant treatments: the confounding role of placebo effectJournal of Pharmacokinetics and Pharmacodynamics, 2012
- Fundamentals of Population Pharmacokinetic ModellingClinical Pharmacokinetics, 2012
- Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry PerspectiveThe AAPS Journal, 2012
- The Prevention and Treatment of Missing Data in Clinical Trials: An FDA Perspective on the Importance of Dealing With ItClinical Pharmacology & Therapeutics, 2012
- Population Pharmacokinetics III: Design, Analysis, and Application of Population Pharmacokinetic StudiesAnnals of Pharmacotherapy, 2004
- Population Pharmacokinetics I: Background, Concepts, and ModelsAnnals of Pharmacotherapy, 2004
- Basic concepts of pharmacokinetic/pharmacodynamic (PK/PD) modelling.1997