Bioequivalence and Bioavailability Forum • Protocol submission in regulatory before initiation BE study

Protocol submission in regulatory before initiation BE study [Regulatives / Guidelines]

posted by gagandeep – 2007-08-18 16:05 (6891 d 07:57 ago) – Posting: # 992
Views: 5,041

Hi Jasmin,

I just want to add one scenario:
If you are doing a BA/BE study of a drug which is not yet marketed / available in India, then you need to prepare protocol and send it to DCGI for approval as a special case. You can only proceed with the trial if you get a no objection certificate from DCGI.
~G

Complete thread:

Protocol submission in regulatory before initiation BE study Jasmin 2007-08-01 07:38
- Protocol submission (EU/US) Helmut 2007-08-01 12:58
- Protocol submission in regulatory before initiation BE study Dr.Sridhar 2007-08-03 14:11
  - Protocol submission mandatory in some countries! Helmut 2007-08-03 14:17
- Protocol submission in regulatory before initiation BE studygagandeep 2007-08-18 14:05
  - Protocol submission in regulatory before initiation BE study Jasmin 2007-08-29 14:11
    - Protocol submission in regulatory before initiation BE study Ahmed meeran 2007-09-17 07:41