The objective of this Working Group (WG) is to study the application of the population bioequivalence (PBE) statistical approach, recommended by the FDA, ANVISA and other agencies, for comparing the in-vitro performance of orally inhaled products (Test versus Reference).
Currently, we are establishing data collection methods and designing a database which will, when populated with the specified data, be used to conduct a simulation study. The simulation study will assess the decision making properties of the PBE statistical approach in the context of in-vitro equivalence of orally inhaled products (Test versus Reference).
An IPAC-RS collaboration with the University of Florida has been launched. The group will study the MCSR tests combined with the Population Bioequivalence as recommended by FDA for determination of equivalence in Aerodynamic Particle Size Distributions.
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.