Bioequivalence and Bioavailability Forum

Dear Suchit,

Is it just that the sponsor changed their mind, or did you already run a first study for Europe, and now you have to repeat the same study for the FDA ?

If it is a repeat from a study already performed: you have to start the whole process once again (new protocol, full IEC/IRB approval, etc.).

If it is the same protocol, and the trial has not yet been performed: you will have to amend the protocol in order to bring it in line with the FDA guidance, which has some differences from EMA's guideline. You will also have a change in the reference product. Also possibly a need to change the subject information form, depending on what was in the initial form. The amendment will need IEC/IRB approval. I can't say about DCGI (is it a new drug, or a modified release formulation ?)

Regards
Ohlbe