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That’s The Way The Tablet Crumbles: Industry Protests FDA Friability Test

 
• By Martin Berman-Gorvine

A split tablet’s structure is compromised by definition and shouldn’t be subjected to friability testing, drug manufacturers argue in response to an FDA draft guidance.

FDA should not impose the proposed friability testing standard for tablets designed to be split, industry commenters said in response to an August draft guidance.

The draft recommends that “tablet splitability at both ends of the proposed hardness range should be demonstrated by: (1) Ensuring...

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