Using Bioequivalence and Particle Size Distribution to Develop OINDPs

The complexity of demonstrating bioequivalence in complex locally acting orally inhaled and nasal drug products is a barrier to the successful commercialization of generics.

This paper details a study to investigate the performance of a population bioequivalence (PBE) test based on particle size distribution measurements generated by morphologically directed Raman spectroscopy. Simulations of PBE trials were conducted across a range of median particle size and span values. Trial optimization strategies are presented based on the observed data and the general applicability of the approach is underlined. Appropriate trial design can help generic developers to avoid underpowered studies when using complex in vitro techniques to demonstrate bioequivalence.