Bioequivalence and Bioavailability Forum • Possible reasons for group effect

Possible reasons for group effect [Design Issues]

posted by GM – India, 2019-07-23 04:23 (584 d 00:05 ago) – Posting: # 20433
Views: 2,337

Hi Helmut and ElMaestro,

Thanks for reply. It helps me a lot.

I have seen one FDA BE review (see link) regarding group effect. Please see page 6 (Reviewer’s Comments) and page 52 (control document).

Here agency is asking for the BE of any one of the group, if group-by-treatment interaction is significant (p<0.05). Is it possible in studies conducted on HVD?

Please provide your thoughts on the same.

—
Best Regards,
GM

Complete thread:

Possible reasons for group effect GM 2019-07-20 07:36 [Design Issues]
- Group “effect” Helmut 2019-07-20 14:02
- Possible reasons for group effect ElMaestro 2019-07-20 19:20
  - Possible reasons for group effectGM 2019-07-23 06:23
    - “Group-by-Treatment Interaction” Helmut 2019-07-23 10:32