Difference between BABE study and clinical trials [Design Issues]

posted by VijithRoy – India, 2020-07-30 15:15 (491 d 00:11 ago) – Posting: # 21807
Views: 2,472

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:

Activity
 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 10 (0 registered, 10 guests [including 9 identified bots]).
Forum time: Friday 14:27 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

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