주요 내용으로 건너 뛰기

Mechanistic PK/PD modeling to address early-stage biotherapeutic dosing feasibility questions

Abstract

Incorporating an early evaluation of dosing requirements is crucial for assessing the viability of a discovery program. If achieving the desired pharmacological effect necessitates an extremely high dose, it might not be practical or commercially viable to pursue the biotherapeutic for the chosen target. This is unless additional steps are taken to create a high-concentration formulation or enhance manufacturing yield. Understanding how target selection, biotherapeutic format, and optimal drug properties influence potential dosing needs can significantly impact early decision-making. Unlike small molecules, predicting dosing requirements for biotherapeutics is feasible due to the strong impact of target biology on pharmacokinetics and dosing. Mechanistic pharmacokinetic/pharmacodynamic (PK/PD) models utilize early-stage data, including target biophysics and disease physiology, to inform drug design. This review explores how mathematical mechanistic PK/PD modeling can be effectively employed to guide early drug development decisions.

Published in mAbs

Author(s): Joshuaine Grant, Fei Hua, Joshua F. Apgar, John M. Burke, Diana H. Marcantonio

Year: 3월 14, 2023

Powered by Translations.com GlobalLink Web Software