DigiM’s Quantitative Image Characterization Featured in FDA Workshop

DigiM Solution LLC, a software and technology solution company, was invited to present at the Food and Drug Administration (FDA) public workshop “Generic Drug Regulatory Science Initiatives,” held virtually on May 4, 2020. Dr. Shawn Zhang, the company’s founder and CEO, presented in “Breakout Session 3: In Vitro Bioequivalence Methods.” DigiM’s presentation, “Image-based Microstructure Bioequivalence Evaluation,” highlighted a novel method to characterize API particles and microporosity in drug products.

The new method consists of high-resolution 3D imaging with FIB-SEM and X-ray Microscopy, quantitative AI image analytics, and image-based dissolution prediction. DigiM offered perspectives on its relevance to both in vitro release performance and establishing Q3 bioequivalence. The purpose of the public workshop was to review GDUFA priorities and product-specific guidelines for complex generic drug products.

In addition to the FDA workshop, DigiM has received an FDA contract to study the correlation of microstructures of complex long-acting drug products with their in vitro release characteristics. For more information on the presentation, please visit: https://vimeo.com/426245847

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