Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology.

ABSTRACT:

Aims

The development of monoclonal antibodies (mAbs) requires an understanding of the interindividual variability (IIV) in pharmacokinetics (PK) at the population level facilitated by population PK (PopPK) modelling. However, there is no clear rationale for selecting which covariates to screen during PopPK model development. Here, we compare the effect of covariates on PK parameters for mAbs in oncology and identify the most commonly used covariates affecting PK parameters.

Methods

All 25 mAbs approved for therapeutic use in oncology until December 2017 by the Food and Drug Administration and the European Medicines Agency were selected for study. Literature searches revealed 23 available PopPK models for these mAbs. To understand the magnitude and types of covariate effect o

SUBMITTER: Bajaj G 

PROVIDER: S-EPMC6710515 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature