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Inhaled Bioequivalence: A Broader View of Product Development


Release date:21/05/2021


Inhaled Bioequivalence

Demonstrating bioequivalence is the key goal for developing generic products – this is particularly challenging for inhaled medicines where the characteristics of drug and device must be considered.

This webcast discusses the key considerations and strategies for demonstrating bioequivalence for both DPIs (dry powder inhalers) and pMDIs (pressurised metered dose inhalers).

Topics include device design, reference product variability, analytical testing and ‘Q3’ methodologies, as well as highlighting the differing regional regulatory requirements how to navigate this complexity.

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