Bioequivalence and Bioavailability Forum • Sample Size and regulators

Sample Size and regulators [Power / Sample Size]

posted by mittyri – Russia, 2016-12-29 12:44 (2460 d 12:56 ago) – Posting: # 16902
Views: 7,850

Hi David and all,

❝ Just curiosity, but does anyone here had questions on sample size from regulators?

some years ago all sponsors who submitted the BEQ protocols to the Russians regulators got a question: how did you calculate the sample size?
There were convinced with any answer: the code in R, values in cells in FARTSSIE, SAS code and output or even justification with some algebra.

—
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 answer mittyri 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 regulatorsmittyri 2016-12-29 11:44
  - Sample Size and regulators Helmut 2016-12-29 12:39