The morphology and chemical composition of complex powder mixtures are often Critical to Quality in pharmaceutical products. Component-specific particle size and shape information measured by the Morphologi 4-ID within a powder blend can help compare the physicochemical attributes of a generic (test) product with the reference listed drug (RLD) in order to establish pharmaceutical equivalence as part of a bioequivalence study, accelerating generic drug development. Here, we present an example case study of the use of MDRS to compare a generic oral solid dose cold and ‘flu product to the RLD, where both products are licensed from the same Marketing Authorization holder.




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