Bioequivalence and Bioavailability Forum • Change in study design and required approval

Change in study design and required approval [Regulatives / Guidelines]

posted by Dr sridevi – India, 2013-07-10 14:28 (4738 d 04:36 ago) – Posting: # 10970
Views: 4,198

Yes we need to apply for fresh approval with DCGI

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Edit: Please follow the Forum’s Policy. [Helmut]

Complete thread:

Change in study design and required approval docksr 2013-07-10 11:13
- Change in study design and required approvalDr sridevi 2013-07-10 12:28
- Change in study design and required approval Naveen Kumar 2013-07-11 09:50
- Change in study design and required approval Karthikeyan 2013-07-15 13:31
  - Three-way with two sequences? Helmut 2013-07-15 13:43
    - Three-way with two sequences? Karthikeyan 2013-07-16 06:10
      - Period effects! Helmut 2013-07-16 13:53