Difference between BABE study and clinical trials [Design Issues]

posted by VijithRoy – India, 2020-07-30 17:15 (1336 d 20:00 ago) – Posting: # 21807
Views: 4,705

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,
Vroy.

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
80 visitors (0 registered, 80 guests [including 8 identified bots]).
Forum time: 12:16 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5