Temple Wants US FDA To Consider Including PK/PD In Labels To Inform Dosing

14 Aug 2019

• By Michael Cipriano

CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject.

pills — Stakeholders discussed the best ways to improve precision dosing at an FDA public meeting.

A top US Food and Drug Administration official suggested that the agency consider adding pharmacokinetic (PK) and pharmacodynamic (PD) analyses to drug labels as a way to inform dose individualization.

Speaking at an 12 August FDA workshop on precision dosing, Robert Temple, the Center for Drug Evaluation and Research’s deputy...