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Highest ADA incidence to justify reduce sampling

  • 1.  Highest ADA incidence to justify reduce sampling

    Posted 07-26-2023 11:27

    Hi Immunogenicity Experts,

    Do you have examples where you dropped a sample collection either in phase 3 or by amendment in an on-going phase 2 because of no ADA +s or low incidence with no impact? If the latter, then what was the low value? equal or lower than 3%? 4%? again with no impact?  I am asking for a study where asking the participants to come back only for ADA (and corresponding PK) seems like a huge burden.

    The idea is to keep the D15 for the first 100 participants.

    Thanks so much for your feedback!!

    Johanna



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    Johanna Mora Ph.D.
    Bristol-Myers Squibb
    Princeton NJ
    [email protected]
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