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

—
Kind regards,
Mittyri
Kind regards,
Mittyri
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 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
- FDA: Budesonide in vitro PBE BE-proff 2016-07-07 13:36