PBE Working Group
Population Bioequivalence (PBE) approach has been recommended by FDA and other regulators as an in vitro bioequivalence test for inhaled drugs. The goals of the IPAC-RS PBE Working group are to better understand the performance properties of the PBE statistical method in terms of its use as a decision making tool for assessing equivalency of in vitro manufacturing data. The PBE WG plans to collect data across the industry. Data will be submitted to the group in a blinded fashion, but in a format that will still allow realistic scenarios and simulations to be conducted. The results of this work are intended to be shared through publication to better serve the industry as a whole in developing decision making tools that are fit for purpose for assessing in vitro equivalency. The working group, to date, has identified and agreed a list of inhaled product types and a list of in vitro tests and is currently reviewing a proposed format for collecting blinded data that will serve as the basis for the simulations.