Pharmacokinetic assessment in patients receiving continuous RRT: perspectives from the Kidney Health Initiative.

ABSTRACT: The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dos

SUBMITTER: Nolin TD 

PROVIDER: S-EPMC4284416 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature