Bioequivalence and Bioavailability Forum

Ok I think I can try answering this one.

Dear Roy,

❝ Clinical trial is the process of new drug development and where as BABE is for already marketed drug (Generic drug).

Well...basically true. A Phase III Clinical Trial is the gold standard for new molecules. For molecules that are already in the market and another company wishes to register it as a generic, he or she mostly resort to BABE Studies.

However there are some additional notes that I must add:

Clinical Trials can also be done for generics but that's not the most appropriate study. So the applicant will have to provide justification why they couldn't do a BABE study instead.

❝ Does BABE study will consider under Clinical Trial studies ?

Well I will say yes and no. Phase I Clinical Trial has some similar components to BABE Studies. That is the pharmacokinetic (Bioavailability) component. Also some applicants include a full BABE study in their list of Clinical Trial Experiments if they made some major modifications on the batch they used for the Phase III Clinical Trial. But technically I'll say no, BABE Studies is not always done under Clinical Trials intended for a new drug application.

❝ Do all the generic drugs undergo BABE study for getting approval ?

Not all. But most.

❝ Thank you in advance.

You are welcome. I'm not 100% certain of my responses though. Hopefully the experts will come in and give a more appropriate response.

Regards