EMA consult: reflectiestuk over onderzoek naar farmacokinetiek en farmacodynamiek in de populatie met obesitas

The European Medicines Agency has released for public consultation a reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population.

The specific aims of this reflection paper are to describe how the effects of obesity can be investigated during clinical drug development, provide recommendations on when investigations of the effect of obesity on the PK of a drug should be considered, provide information on specific important considerations for these investigations and discuss how to reflect PK findings in weight/size based dosing recommendations.

The draft reflection paper is available by clicking here.

Comments should be provided using this template and sent to pkwp@ema.europa.eu by 31/07/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

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