Investigating the microstructure of dry powder inhalers (DPI) using orthogonal analytical approaches
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G Farias, W Ganley, D Huck-Jones, P Kippax, J Shur…
2017
materials-talks.com
With several patent expirations of innovator dry powder inhaler (DPI) products looming, the major challenge for generic entry is demonstrating bioequivalence (BE) with respect to the reference product. Demonstrating BE of locally acting drugs is challenging, because they do not rely on systemic circulation for targeting the therapeutic site of action. The US FDA has conceived a concept for demonstrating BE of topical products, which is called Q3-equivalence. This term describes structural similarity between test and reference products …
