Scientific Publications by FDA Staff

AAPS J 2020 Jan 6;22(2):25

Expert discussion of the role of rate constant versus clearance approaches to define drug pharmacokinetics: theoretical and clinical considerations.

Martinez MN, Jelliffe RW, Proost JH

This article provides a dialogue covering an ongoing controversy on the use of clearance versus rate constant approaches for model parameterization when assessing pharmacokinetic (PK) data. It reflects the differences in opinions that can exist among PK experts. Importantly, this discussion extends beyond theoretical arguments to demonstrate how these different approaches impact the analysis and interpretation of data acquired in clinical situations. By not shying away from such dialogues, this article showcases how dissimilarity in well-grounded perspectives can influence how one applies PK and mathematical principles.