Bioequivalence and Bioavailability Forum • Another Master's answer

Another Master's answer [Power / Sample Size]

posted by mittyri – Russia, 2016-12-28 12:38 (3457 d 17:26 ago) – Posting: # 16896
Views: 11,225

Hi BE-proff,

My answer is: 'Educated Guess'
No one will decide which GMR you should use behind your back.
Fully ACK the ElMaestro's answer below.
I'd cite another Master's post:

❝ If you intend the next study to be pivotal then the choice of GMR guess should reflect a ton of factors including biology, dissolution, gut feeling, Saturn's moons, your biorhythms, personal horoscope (you've gotta ask yourself one question: "Do I feel lucky?" Well, do ya, punk?) etc but not your management's desire to save money.

Please also think about GMR = 1.19
Would you recommend to use the formulation with REAL GMR = 1.19 in practice?

—
Kind regards,
Mittyri

Complete thread:

Sample Size II BE-proff 2016-12-28 08:14 [Power / Sample Size]
- Please see the answer to your previous post mittyri 2016-12-28 09:17
  - Please see the answer to your previous post BE-proff 2016-12-28 10:35
    - Another Master's answermittyri 2016-12-28 11:38
- Sample Size II ElMaestro 2016-12-28 10:52
- Expected power answer d_labes 2016-12-28 13:42
- Sample Size and regulators DavidManteigas 2016-12-28 18:11
  - Sample Size and sponsors d_labes 2016-12-28 19:24
    - Sample Size and spongulators ElMaestro 2016-12-28 22:22
  - Sample Size and regulators mittyri 2016-12-29 11:44
  - Sample Size and regulators Helmut 2016-12-29 12:39