GastroPlus in Model-informed Drug Development: PBPK Modelling, ACAT Modelling, and Regulatory Relevance

Authors: Kamal M
Publication: The International Journal of Multidisciplinary and Medical Research
Software: GastroPlus®

Abstract

GastroPlus is a popular mid-21st century modeling software used in the drug development world to simulate in vivo drug behaviours based on in vitro and physicochemical data. It combines the most important parameters of solubility, permeability, dissolution, particle size, pKa and gastrointestinal physiology to mimic drug absorption, distribution, metabolism and excretion (ADME). To make it easier to anticipate plasma concentration–time profiles in various physiological and dosage settings, the platform integrates sophisticated compartmental modeling of the gastrointestinal tract and systemic pharmacokinetic processes.Additionally, GastroPlus is a crucial tool in drug development for dose selection, bioavailability increase, formulation design optimization, and reducing the need for extensive animal and human research. It turns out to be a useful technique for preclinical and clinical assessments to determine how food, disease states, and population variability affect drug efficacy. Furthermore, it can be integrated with pharmacokinetic and pharmacodynamic (PK/PD) modeling, which helps in lead optimization and regulatory submissions.GastroPlus is a complete in silico tool that can improve oral medication absorption and systemic exposure prediction accuracy, reduce development costs, shorten time to market for new therapies, and increase efficiency.

By Mutiba Kamal