PBPK-based translation from preclinical species to humans for the full-size IgG therapeutic efalizumab.

ABSTRACT:

Introduction

Animal models play a vital role in pharmaceutical research and development by supporting the planning and design of later clinical studies. To improve confidence and reliability of first in human dose estimates it is essential to assess the comparability of animal studies with the human situation. In the context of large molecules, it is particularly important to evaluate the cross-species-translatability of parameters related to neonatal fragment crystallizable receptor (FcRn) binding and target mediated drug disposition (TMDD), as they greatly influence distribution and disposition of proteins in the body of an organism.

Methods

Plasma pharmacokinetic data of the therapeutic protein efalizumab were obtained from literature. Physiologically based pharmacokineti

SUBMITTER: Franz M 

PROVIDER: S-EPMC11473394 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature