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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.
Download this free webcast where Martin Oliver, SVP Delivery Management, and a cross-functional team discuss the key considerations and strategies for demonstrating bioequivalence for both dry powder inhalers (DPIs) and pressurised metered dose inhalers (pMDIs).
Topics include inhaler design, reference product understanding, analytical testing and ‘Q3’ methodologies, as well as highlighting differing regional regulatory requirements and how to navigate this complexity.
The webcast highlights the critical role bioequivalence testing plays across the product lifecycle, and how new methodologies may help accelerate development and introduce lifecycle management design changes.