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In Silico Bioequivalence – Particle Size Distribution

In Silico trial to replace Bioequivalence trial for formulation with different particle size distribution (PSD)


The Sponsor intended to have a bio-waiver for the formulation prepared with revised PSD of API. The Sponsor had performed a BA BE study with the earlier proposed PSD of API.

Question of Interest

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


BA BE data of the test product and the reference were used in the analysis.

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


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


·      The Agency accepted the Sponsor’s revised API PSD limits including the in silico BA BE study.

·      The Sponsor reduced costs and timelines of the new formulation development program.

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