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

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

posted by docksr – India, 2013-07-10 13:13 (4731 d 20:49 ago) – Posting: # 10969
Views: 4,843

If a three-way crossover design protocol (T1, T2 and R or T with R replicate) with N=X is approved by DCGI for a particular study, and the design is changed to a two-way cross over with >N=X, do we need to seek fresh approval or make necessary amendments to the previously approved protocol

Edit: Please follow the Forum’s Policy. [Helmut]

Complete thread:

Change in study design and required approvaldocksr 2013-07-10 11:13
- Change in study design and required approval Dr 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