What is it about?
In order to ensure clinical performance of drug products, bioequivalence studies BE should be performed. The demonstration of BE is often based on plasma data. The urinary excretion method is recommended for BE in case of drugs that are not metabolised. This is a less invasive method and it has low costs.
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Why is it important?
Our findings show that the drugs Glucophage and Metformine (tablets 850 mg) exhibit a similar elimination rate, which indicates a similarity in their bioavailability and bioequivalence. Due to the high invasiveness of BE studies, the prediction of absorption can be performed using the urinary excretion method. Furthermore, the urinary excretion method is an invasive method and it represents low costs.
Perspectives
When I joined a Bioequivalence Study Project, I asked myself "Will I pass this tough time?" Thank to my mentor and co mentor, we did a beautiful journey. All life is an experiment. Important thing is to be curious and unstoppable. I recommend BE study to be perform for all drugs to understand better clinical performance and their safety.
PhD Eva Troja
Profarma Sh.a
Read the Original
This page is a summary of: Assessment of Bioequivalence Using Urinary Excretion Data: A Review, May 2024, Sciencedomain International,
DOI: 10.9734/bpi/prrat/v2/679.
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