Bioequivalence and Bioavailability Forum • FDA: Budesonide in vitro PBE

FDA: Budesonide in vitro PBE [Power / Sample Size]

posted by ElMaestro – Denmark, 2016-07-07 15:57 (3290 d 01:40 ago) – Posting: # 16476
Views: 8,045

Hi Hötzi,

I believe you need to set up a resampling/bootstrap method.

This is where communication is of utmost importance. In companies where sample size for BE is of interest, it usually takes 5 minutes and a minimum of googling to get a sample size. Here it will take about 100 hrs of programming time and you cannot validate it because noone has a dataset with known result. Tough sh!t.

—
Pass or fail!
ElMaestro

Complete thread:

FDA: Budesonide in vitro PBE Helmut 2016-07-07 13:16 [Power / Sample Size]
- FDA: Budesonide in vitro PBE BE-proff 2016-07-07 13:36
  - asking the FDA… Helmut 2016-07-07 13:44
- FDA: Budesonide in vitro PBEElMaestro 2016-07-07 13:57
  - FDA: Budesonide in vitro PBE Helmut 2016-07-07 14:12
- FDA: Budesonide in vitro PBE mittyri 2016-07-07 14:17
  - FDA: Budesonide in vitro PBE Helmut 2016-07-07 14:25