Thomas D Nolin, George R Aronoff, William H Fissell, Lokesh Jain, Rajnikanth Madabushi, Kellie Reynolds, Lei Zhang, Shiew Mei Huang, Rajnish Mehrotra, Michael F Flessner, John K Leypoldt, Jennifer W Witcher, Issam Zineh, Patrick Archdeacon, Prabir Roy-Chaudhury, Stuart L Goldstein
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...
January 7, 2015: Clinical Journal of the American Society of Nephrology: CJASN