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

Dear Mr Suchit Bhavsar,
You cannot conduct the study with the same approved protocol with amendments of regulatory and IP details. You need to make a fresh protocol or new version of old protocol to make these changes. The new protocol or new version of the old protocol should be submitted again to the DCGI and Ethics Committee before initiating the study.