Virtual bioequivalence assessments have emerged as a valuable tool in the pharmaceutical industry, particularly for evaluating orally administered drugs. This approach leverages computational modeling and simulation to predict how different drug formulations compare to each other in terms of their pharmacokinetic profiles. The primary advantage of virtual bioequivalence is its potential to reduce the need for extensive in vivo testing, thereby accelerating drug development and lowering costs. However, ensuring the accuracy and reliability of these virtual assessments remains a challenge. This article explores current methodologies for virtual bioequivalence, discusses their benefits and limitations and proposes strategies for improving their efficacy. Advances in computational power, modeling techniques and integration of real-world data are highlighted as key factors that could enhance the precision of virtual bioequivalence evaluations.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
