Bioequivalence and Bioavailability Forum

Dear fedesalas,

❝ For example, for oral solid forms for systemic action:

❝ a) The test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified."

❝

❝ But if the bio batch used in the BE study was lower than 100 000 tablets, in what way we can justify this?

If the intended production batch size is smaller than 100,000 units, then you have to use a full size batch. This may happen for drugs with a very small market: if you plan to have a production batch size of 50,000 because the sales are very limited (orphan drug product), then use this for your biobatch.

If the expected sales are millions of tablets per year, don't even think of claiming a batch size of 50,000 because that's what you used in your BE. It won't work. The Agencies won't believe you and your dossier is likely to get rejected. If the study has already been performed: too bad. Too late. The justification should come before the trial, not after...