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

posted by mittyri – Russia, 2016-07-07 16:17 (3138 d 01:55 ago) – Posting: # 16478
Views: 7,600

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"?:-D

Kind regards,
Mittyri

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