Can we administer ge­neric drug as conco­mi­tant in patient based PK study [Regulatives / Guidelines]

posted by narra1813  – India, 2025-10-14 15:20 (232 d 17:00 ago) – Posting: # 24453
Views: 1,294

hi

Can you please advice regulatory views on concomitant medication should be used from FDA approved data base or locally approved generic can be used in Patient based PK study. as this concomitant is will used for reducing severity of AE.
—
Regards

Narra Narendra Babu

Complete thread:

UA Flag
Activity
 Admin contact
23,653 posts in 4,991 threads, 1,571 registered users;
330 visitors (0 registered, 330 guests [including 16 identified bots]).
Forum time: 08:20 CEST (Europe/Vienna)

I’m all in favor of the democratic principle
that one idiot is as good as one genius, but I draw the line
when someone takes the next step and concludes
that two idiots are better than one genius.    Leo Szilard

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