Allometric scaling of therapeutic monoclonal antibodies in preclinical and clinical settings.

ABSTRACT: Constant technological advancement enabled the production of therapeutic monoclonal antibodies (mAbs) and will continue to contribute to their rapid expansion. Compared to small-molecule drugs, mAbs have favorable characteristics, but also more complex pharmacokinetics (PK), e.g., target-mediated nonlinear elimination and recycling by neonatal Fc-receptor. This review briefly discusses mAb biology, similarities and differences in PK processes across species and within human, and provides a detailed overview of allometric scaling approaches for translating mAb PK from preclinical species to human and extrapolating from adults to children. The approaches described here will remain vital in mAb drug development, although more data are needed, for example, from very young patients and mAbs wit

SUBMITTER: Germovsek E 

PROVIDER: S-EPMC8463036 | biostudies-literature | 2021 Jan-Dec

REPOSITORIES: biostudies-literature