Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

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Download document Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function
Reference number EMA/83874/2014
Status draft: consultation closed
First published 2014-02-28
Last updated 2014-02-28

Summary

Pharmacokinetic studies can be used to estimate drug exposure in subpopulations of patients with characteristics that might affect the pharmacokinetics of the drug, and alternative dosing regimens may be developed based on the degree of change in exposure and the pharmacokinetic/pharmacodynamic (PK/PD) relationship. Pharmacokinetic data can, thus, be used to extrapolate efficacy and safety data from the phase III population to subpopulations that were not sufficiently represented in the phase III study.