Bioequivalence and Bioavailability Forum • power.TOST (CV & n; everything else optional

power.TOST (CV & n; everything else optional—with defaults) [🇷 for BE/BA]

posted by Ken Peh – Malaysia, 2013-07-30 21:03 (4344 d 22:20 ago) – Posting: # 11133
Views: 5,261

Dear Helmut,

Thank you very much for your prompt reply.

❝ Oh, is your authority still requiring this? :no:

Yes, it is still in the guideline. I have brought this up to the authority but it has not been discussed yet.

The generic is BE to comparator but the power is less than 80%. Will leave it out and answer when asked by the authority.

Regards,
Ken

Complete thread:

calculation of power with power.TOST Ken Peh 2013-07-29 19:03
- power.TOST (CV & n; everything else optional—with defaults) Helmut 2013-07-29 21:30
  - power.TOST (CV & n; everything else optional—with defaults) ElMaestro 2013-07-29 21:54
    - power.TOST acceptance range unbalanced d_labes 2013-07-30 11:57
      - power.TOST acceptance range unbalanced Ken Peh 2013-07-30 18:53
  - power.TOST (CV & n; everything else optional—with defaults)Ken Peh 2013-07-30 19:03