A Quantitative Systems Pharmacology Model Describing the Cellular Kinetic-Pharmacodynamic Relationship for a Live Biotherapeutic Product to Support Microbiome Drug Development

Published in Clinical Pharmacology & Therapeutics

9
May
Early Feasibility Assessment: An innovative approach to gain confidence in therapeutic discovery
May 9, 2023

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

Published in mAbs

Early Feasibility Assessment: A Method for Accurately Predicting Biotherapeutic Dosing to Inform Early Drug Discovery Decisions

Abstract

Model-informed drug discovery and development (MID3) uses mathematical modeling to inform decision-making in drug development programs. Applying MID3 early in development can reduce late-stage risk by determining feasibility of drugging a given target, prioritizing between targets, or defining optimal drug properties for a target product profile. However, the lack of pharmacokinetic (PK) and pharmacodynamic (PD) data available at early stages can make modeling a challenge.

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