Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population

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Download document Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population
Reference number EMA/CHMP/535116/2016
Status draft: consultation open
First published 2018-02-01
Last updated 2018-02-01
Consultation start date 2018-02-01
Consultation end date 2018-07-31
Email address for submissions pkwp@ema.europa.eu

Summary

Obesity affects a large sub-set of the general population covering all ages and will continue to increase based on observed trends. The alteration of body composition and physiology as well as steatosis and a chronic state of inflammation (1) can potentially lead to important changes in the disposition of a given drug in obese as compared to non-obese subjects.