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Inhaler Bioequivalence Using Combined CT Imaging and FEV1 – A Crossover Study Design to Demonstrate Improved Statistical Power in a Small Number of Subjects

De Backer J.

RDD Europe 2013. Volume 1, 2013: 77-84.

Abstract:

Demonstrating bioequivalence of inhaled drugs has proven to be quite challenging. While in Europe it is sufficient to demonstrate in vitro, pharmacokinetic or pharmacodynamic equivalence, in the US it is necessary to demonstrate all three. Using existing outcome parameters, large variability is required to fulfill the equivalence criteria. A recently developed functional respiratory imaging (FRI) method, consisting of a combination of multi-slice CT imaging and computational fluid dynamics (CFD), provides a more detailed description of the structural and functional changes introduced into the respiratory system by a specific therapy. Consequently, FRI may be used to assess the efficacy of new or existing compounds or investigate equivalence of two compounds. The enhanced sensitivity makes it possible to perform small, sufficiently powered clinical trials making it both an analysis method and design tool.