Difference between BABE study and clinical trials [Design Issues]

posted by VijithRoy – India, 2020-07-30 15:15 (281 d 05:56 ago) – Posting: # 21807
Views: 2,010

Dear all,

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

Does BABE study will consider under Clinical Trial studies ?

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

Thank you in advance.

With Best Regards,

Complete thread:

 Admin contact
21,445 posts in 4,482 threads, 1,511 registered users;
online 17 (0 registered, 17 guests [including 2 identified bots]).
Forum time: Friday 21:12 CEST (Europe/Vienna)

The plural of anecdote is not data.    Roger Brinner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz