Conference Talk | Current analytical trends and developments for in-vitro in-vivo correlation of respiratory products

During the 13th PharmSci International Conference, our Technical Director, Mark Parry, will present on "Current analytical trends and developments for in-vitro in-vivo correlation (IVIVC) of respiratory products"

The development of generic inhaled drug products can represent a complex set of challenges. These include the development of equivalent physical performance but also demonstrating suitable bioequivalence. PK and endpoint clinical trials are time-consuming, costly, and require potentially avoidable patient dosing. While the current regulatory guidance, especially for the EU and USA, provide the option to submit in-vitro only applications, building confidence in the in-vitro bioequivalence data has driven increasing exploration of models, tools and techniques for better understanding the correlation between in-vitro and in-vivo performance.

This presentation will review the current trends and approaches being used to build enhanced IVBE studies and how these can also improve the development of novel API based drug products.

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Our team would be delighted to share the slide after the event.