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

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Deadline for comments: 31/07/2018

Reference numberEMA/CHMP/535116/2016
Effective from
KeywordsObese, pharmacokinetics, pharmacodynamics, dosing recomm
DescriptionObesity 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. Thus, the need for adequate pharmacokinetic (PK) characterisation in obese subjects should be considered in drug development to ensure their effective and safe use in this subgroup and to inform on possible dose adjustments required in these patients. Note, the term 'non-obese' includes both normal/lean subjects and underweight subjects.

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