Hi Community,
Can someone please remind me if there is any guidance regarding PK and immunogenicity assessment of co-meds? I have seen may examples of small molecules co-dosed with the biotherapeutic in development and no assessment being done for the small molecule. I have seen, however, the assessment performed for a co-dosed biologic, let's call it "A", with the biotherapeutic in development, "B". Of course, all assessments are needed for "B". I understand the reasons why the information would be nice to have, confirm through levels of "A"; confirm that "B" does not impact the immunogenicity of "A". I am interested in knowing if it is required or is it acceptable to collect and bank and NOT analyze, the immunogenicity samples of "A" unless there is impact on through levels of "A". Does anyone think of a scenario where we don't need through levels of "A"?
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Johanna Mora Ph.D.
Bristol-Myers Squibb
Princeton NJ
[email protected]------------------------------