A new statistical method to assess in vitro bioequivalence of nasal products

A new statistical method to assess in vitro bioequivalence of nasal products

A new statistical method to assess in vitro bioequivalence of nasal products

Bioequivalence testing is an essential step during the development of generic drugs. Despite recommendations and guidelines from Regulatory authorities on the methodology, there is no consensus and statistical approaches differ according to geographical regions; most of the time with limitations (e.g. when batch variability is non negligible).

Hence, Nemera has developed an alternative statistical method to evaluate in-vitro bioequivalence, applied to nasal sprays, while considering the between-batch variability.

This article presents the so called Between-Batch Bioequivalence (BBE) method, evaluated through both simulation and real-case (Nasonex® & Flonase®) studies.

With this unique approach of reading statistics, BBE could be considered as an alternative to the state-of-the-art methods allowing costless development.

Bio-eq


To read the full article: Article_Between-BatchBioequivalenceBBE


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As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are the utmost holistic partner and help our customers succeed in the sprint to market. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.
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