miQ3: Lowering the Barrier to Successful ANDA Filings with a RLD Microstructure Database

Microstructure plays a pivotal role throughout the development and regulatory submission process for Abbreviated New Drug Applications (ANDAs). Attributes such as porosity, surface area, particle size, ingredient distribution, pore size, coating thickness, and density can profoundly influence manufacturability and product performance. Establishing Q3 structural equivalence is a key component of an ANDA filing; however, demonstrating this equivalence can be both technically challenging and resource intensive. Generating a comprehensive data package for regulatory submission requires not only detailed structural characterization of the generic product throughout development, but also comparable data for the reference listed drug (RLD), information that is typically unavailable through public NDA filings.

In this webinar, the role of microstructure characterization in supporting Q3 equivalence will be explored, along with practical strategies to streamline the development and regulatory process. The session will introduce miQ3, a new database that catalogs the microstructural properties of reference listed drugs (RLDs), significantly reducing the time, cost, and complexity associated with sourcing and characterizing RLD samples. Case examples will highlight how leveraging this database can accelerate development timelines, improve formulation design, and strengthen regulatory submissions.

Key Learning Outcomes:

• Understand the critical role of microstructure in achieving Q3 structural equivalence for ANDA filings.
• Learn how advanced microstructural data and databases such as miQ3 can reduce RLD characterization costs and development time.
• Explore case studies demonstrating how microstructure insights can inform formulation optimization, process development, and regulatory strategy.

For more information on miQ3 see our press release here.

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