Friday, September 20, 2024

Nextgov: FDA Wants to use AI to Assess Pharmaceuticals

The Food and Drug Administration is looking to use artificial intelligence to help characterize pharmaceutical products , according to a small business sources sought notice filed on Wednesday.

The FDA’s Division of Product Quality performs research “to advance the adoption of emerging technology for pharmaceutical manufacturing” and for the development of generic drugs, the notice stated. As a result, the division is looking for a contractor to provide high-resolution images and perform an analysis of the images with artificial intelligence to characterize “freeze-dried pharmaceuticals and complex drug products.”…

“Physical and microstructural parameters are attributes of a freeze dried drug product,” an FDA spokesperson told Nextgov. “The ability to readily measure these attributes could enable an understanding of how these attributes are impacted by changes to a manufacturing process and how changes in these attributes might impact drug product performance. Similarly for complex products, microstructural parameters can impact drug release. The microstructure of a complex product can be influenced by the formulation and the manufacturing process.”

Artificial intelligence could then give the FDA another method of examining such characteristics…

Read the full article here.

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