Regulatory Open Forum

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  • 1.  Similarity of dissolution profiles

    Posted 12-May-2022 03:39
    Dear Colleagues

    As a BE assessor I have come across issues where the applicant is unable to demonstrate similarity between a Biobatch and a lower strength at pH 1.2 and 4.5 citing API related issues. Similarity was only demonstrated at pH 6.8 only. what is your view with regards to granting of additional strength biowaiver considering that similarity was only demonstrated at  pH 6.8.??.


  • 2.  RE: Similarity of dissolution profiles

    Posted 20-May-2022 11:05
    Dear Sakeni,

    I assume the API in question is either BCA Class 1 or Class 3. If that is the case, then I would refer to the clear guidelines outlined in ICH M9, where you will find that demonstration of rapid dissolution at the three different pH values is a requirement to claim a biowaiver.

    Hope this helps,

    Maurizio Franzini
    Regulatory Affairs CMC, Director
    San Francisco CA
    United States