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  • 1.  Extending Clinical Dosing Beyond 13 weeks without completing 9-month non-rodent repeated dose tox study

    This message was posted by a user wishing to remain anonymous
    Posted 14 days ago
    This message was posted by a user wishing to remain anonymous

    ICH M3 (R2) Table 1 footnote b) notes "For serious or life-threatening indications or on a case-by-case basis, the extension can be supported by complete chronic rodent data and in-life and necropsy data for the non-rodent study. Complete histopathology data from the non-rodent should be available within additional 3 months.

    Has this approach been accepted by the FDA Division of Neurology? 



  • 2.  RE: Extending Clinical Dosing Beyond 13 weeks without completing 9-month non-rodent repeated dose tox study

    Posted 14 days ago

    Hopefully someone with direct Division of Neurology experience can respond to your specific question. However, from a general regulatory strategy perspective, I would be confident that this ICH standard would be accepted across FDA. There are many factors to consider in how FDA might respond but it is certainly something to propose and to get some feedback before implementation. I have been able to negotiate approaches that would meet your objectives. For example, depending on the clinical study timing and availability of tox data it may be possible to start the clinical study in parallel with the tox studies so that they are completed by time patients have been treated for the full duration as long as there are no other safety signals that might raise concerns. 



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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    Original Message


  • 3.  RE: Extending Clinical Dosing Beyond 13 weeks without completing 9-month non-rodent repeated dose tox study

    Posted 14 days ago

    Hello,

    I agree with Glen and I would add that the best way is to ask FDA. I have a client who is currently running additional toxicology study in parallel with the current study but they have FIH data. I guess it depends on your case and what kind of data you have.

    Good luck with your study.

    Olga 



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    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
    ------------------------------

    Original Message


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