Performance Testing for Dry Powder Inhaler Products: Towards Clinical Relevance

It is well established that the critical performance metrics for aerosol products are aerodynamic particle size distribution (APSD) and delivered dose uniformity (DDU). In broad terms, these characteristics dictate efficiency reproducibility with which an administered clinically. However, properties alone do not support in-vitro, in-vivo correlations. There have been numerous publications attempting to more directly link product testing physiological relevance or further draw direct correlations of bioequivalence development generic products. While novel methods employed in activity, their suitability compendial has yet be established. This paper explores potential establish biologically relevant standards dry powder inhaler while maintaining accuracy data collected quality product.