Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

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 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.

Keywords: Obese, pharmacokinetics, pharmacodynamics, dosing recommendations

Current version

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Consultation dates: 01/02/2018 to 31/07/2018AdoptedReference Number: EMA/CHMP/535116/2016

Document history

Draft reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population

Consultation dates: 01/02/2018 to 31/07/2018AdoptedReference Number: EMA/CHMP/535116/2016Summary:

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.

Keywords: obese, pharmacokinetics, dosing recommendations