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In Silico Bioequivalence – Non-Proportional Formulation

In Silico trial to replace Bioequivalence trial for non-proportional formulation


The Sponsor intended to have a biowaiver for the non-proportional lower strength. The Sponsor had performed a BA BE study with the higher strength. 

Question of Interest

Could Modeling and Simulation replace the BA BE trial by an in silico BA BE?


BA BE data of the higher strength and PK data of the reference for the lower strength were used in the analysis.

The in-silico BA BE trial was performed by means of IVIVC modeling.


A validated IVIVC model (see figure) was developed and used to simulate the BA BE trial.


·      The Agency accepted the Sponsor’s clinical development program including the in silico BA BE study.

·      The Sponsor reduced costs and timelines by waiving off the BA BE study for lower strengths.

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