BABE ∈ Phase I [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2020-07-30 16:35 (490 d 22:42 ago) – Posting: # 21809
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Hi VijithRoy,

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

Not quite. For a generic you aim to demonstrate BE. Only if the applicant succeeds, it will be approved and can be marketed. BE is also required for originators when scaling up from the batches (likely less than 10,000 units) used in their Phase III trials to the final production batch size (sometimes millions of units) and for any drug if the formulation is substantially modified (for minor changes in vitro similarity is sufficient).


There are no “BE studies”. Bioequivalence is the desired outcome of a comparative bioavailability study. Only Health Canada got it in its guidelines right. ;-)


» Does BABE study will consider under Clinical Trial studies ?

Yes. Phase I (human pharmacology). Mostly healthy volunteers, sometimes patients.
Rarely I saw “Phase I/IV” mentioned in protocols/reports. The idea behind was that the generic is in Phase I and the originator in Phase IV (post-marketing). That’s not correct since in Phase IV solely patients are studied (and rarely under controlled conditions).

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

No. If in BCS class I (or under certain conditions in class III) a BCS-based biowaiver is possible.

PS: Consider this post as a refresher.

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Helmut Schütz

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