Virtual Bioequivalence Applications in Drugs

Abstract

Objective: Virtual bioequivalence studies play a critical role in facilitating and optimizing drug development processes of new drugs and generic drugs. This approach relies on mathematical calculations to mimic and predict the behavior of drugs in the human body. Virtual bioequivalence studies can assess the pharmacokinetic and clinical performance between test and reference formulations by utilizing in vitro, in silico and in vivo data. This enables the prediction of drug effects and optimization of dosage. Result and Discussion: The regulatory position of virtual bioequivalence studies has not yet been fully determined, making collaboration among regulatory authorities, the pharmaceutical industry, universities, and research institutions crucial. Particularly for drugs administered orally or through other systemic routes, determining the framework of physiologically-based pharmacokinetic and biopharmaceutical modeling studies through virtual bioequivalence is important to support exemptions and optimization from in vivo clinical trials. Virtual bioequivalence studies can be a significant tool in improving drug development processes, reducing time, and cutting costs. However, continued progress in this field and further integration of these methods into drug-related regulatory processes are necessary. © 2024 University of Ankara. All rights reserved.