Population Bioequivalence (PBE) DISCUSSION GROUP
The objective of the PBE 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).
Pharmacokinetics (PK) BATCH TO BATCH VARIABILITY DISCUSSION GROUP
This Discussion Group is exploring statistical implications of the current regulatory requirements for PK testing, given batch-to-batch within-subject variability of PK results.