Bioequivalence and Bioavailability Forum

Hi,

Solicit your opinion / guidance on the below.

We had submitted generic version of X product without BE. The Waiver for the same based on the BCS classification. Off late the review of the dossier has raised question on the BE with notification to submit the data by conducting the same.

To update, the registration samples were submitted from the commercial lot and assigned 24 months shelf life. Now the proposed shelf life of 24 months is complete for the product and QC analysis of the last due point indicate the samples to be well confined to the shelf life specification.

Hence could you confirm that the samples manufactured 24 months back will still be a good candidate for BE as Test product versus the fresh lot of the innovator ?

Is there any time regulatory time frame where in the time lag between the formulation manufactured and the BE conducted is freezed / discussed ?

If not, how could I support the BE using the old samples to the regulatory body ?

If not I may have to take fresh commercial lot and do the same.

Thanks