Remarkable Pharmacokinetics of Monoclonal Antibodies: A Quest for an Explanation.

ABSTRACT: Monoclonal antibodies (MAbs) usually display slow and limited distribution with combined linear and non-linear elimination mechanisms. While studying individual pharmacokinetic profiles, it was noticed that MAb plasma concentration can vary abruptly over time, with one or more increases after the time to maximum plasma concentration when theoretically the concentration should only decline. This article summarizes the frequency of these additional peaks and assesses whether normal intra-subject and assay variability can explain the observations. For this analysis, we used a benchmark consisting of three registered (adalimumab, bevacizumab, and trastuzumab) and three unregistered immunoglobulin G1 MAbs. At a selected 'normal' intra-subject variability of 12%, at least 70% of the study partic

SUBMITTER: Reijers JAA 

PROVIDER: S-EPMC5563346 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature