Bioequivalence and Bioavailability Forum • Add-on study data combining procedure

Add-on study data combining procedure [Two-Stage / GS Designs]

posted by msmnainar – India, 2013-02-14 09:08 (4511 d 07:01 ago) – Posting: # 10018
Views: 8,235

Dear All

Could you confirm how to combine the initial study BE data with add-on study, considering the Healthy Canada regulations.

Request you to address the following queries,

Steps to follow to combine the data from initial study and add-on study
Alpha level to be used
Confidence Interval to be adopted

Thanks and Regards

Edit: Category changed. [Helmut]

—
Sundar. M

Complete thread:

Add-on study data combining proceduremsmnainar 2013-02-14 08:08
- Add-on study data combining procedure drgunasakaran1 2013-02-14 09:54
  - Add-on study data combining procedure msmnainar 2013-02-14 10:39
    - Ref’s for Methods C/D Helmut 2013-02-14 13:32
      - Ref’s for Methods C/D msmnainar 2013-02-14 13:40
  - No more add-ons for submissions in Canada Helmut 2013-02-14 13:22