Bioequivalence and Bioavailability Forum

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

posted by mittyri  – Russia, 2016-07-07 16:17 (3633 d 02:19 ago) – Posting: # 16478
Views: 9,169

Hi Helmut,

If I understood correctly, simulation is the best choice, something like this:
Morgan B, Strickland H. Performance Properties of the Population Bioequivalence Approach for In Vitro Delivered Dose for Orally Inhaled Respiratory Products. The AAPS Journal. 2014;16(1):89-100. doi:10.1208/s12248-013-9543-x.

Is that an enhancement request to "Swiss army knife for lazy guys dealing with BE studies"?

Complete thread:

• FDA: Budesonide in vitro PBE Helmut 2016-07-07 13:16 
  • 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 PBE ElMaestro 2016-07-07 13:57
    • FDA: Budesonide in vitro PBE Helmut 2016-07-07 14:12
  • FDA: Budesonide in vitro PBEmittyri 2016-07-07 14:17
    • FDA: Budesonide in vitro PBE Helmut 2016-07-07 14:25