Exploring In Vitro-Only Bioequivalence Pathways for Generic Nasal Suspensions

During our RDD 2024 Workshop, join Chris Vernall, Commercial Director, and Ben Stafford, Senior Analyst, as they explore IVBE test packages for generic nasal suspensions. Gain practical tips for overcoming challenges presented by complex techniques including Morphologically Directed Raman Spectroscopy (MDRS) and dissolution.

In 2023, the US FDA introduced new draft guidance for nasal suspension product bioequivalence (BE) requirements, providing a fully "in vitro-only" approval pathway. This workshop will explore robust testing package design for such studies. We will discuss traditional in vitro spray characterization tests for generic product submissions (SAC, DPS, SP, DISP, DSD, PG, Priming/Re-priming). We shall also address advanced techniques such as MDRS and dissolution studies, emphasizing their relevance to establishing bioequivalence, the challenges posed by these complex techniques, and how to overcome them.

Why should you attend?
Participants can expect to gain a thorough understanding of how to design and execute MDRS and dissolution studies for nasal suspension products, and how these fit more widely into formal IV-BE packages for generic submissions.

Not attending RDD and would like a copy of our workshop?
Please complete the form to request a copy. Our team will be delighted to share the recording after the event.