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Changing the Similarity factor to meet new ICH guidelines for Dissolution Curve F2 Analysis

Hi All,

A customer let me know that there has been an update to ICH M13B (p.7) for dissolution analysis that allows similarity factor calculations when there are noisy samples (>8 SD, see the diagram below).

From our platform we use a limit of 50 as the standard F2 Analysis: "Standard bootstrap confidence intervals as also provided. If the lower limit for F2 is greater than 50, then the conclusion is that the dissolution of the test tablet is similar to the dissolution of the reference tablet ".

Is there any way to change this value of 50? Or is there a manual way to do this calculation as a workaround?

Thanks!
Ben

Re: Changing the Similarity factor to meet new ICH guidelines for Dissolution Curve F2 Analysis

Thank you @Ben_BarrIngh , we will revise your request and come back to you.

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