Regulatory Open Forum

 View Only

  • 1.  Non-GLP explorations in a GLP study

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2023 09:19
    This message was posted by a user wishing to remain anonymous

    Dear Colleagues,

    How would you deal with a situation where a sponsor wants to do an exploratory PK/PD analysis from GLP study samples at their own lab, and those exploratory analysis were not described in the GLP protocol? The in-life portion of the study has already been completed, but the GLP study report has not been finalized yet.

    Would you make a protocol amendment (albeit late), and include the results in the final report?

    What about not reporting this exploratory non-GLP portion in study documents at all??

    The PK/PD results might be relevant for the human dose justification, although maybe not critical.



  • 2.  RE: Non-GLP explorations in a GLP study

    Posted 16-Jun-2023 09:28

    Good regulatory advice would be that any analysis should be reported, so that determinations for safety and efficacy can be made and the product development history can be followed through out the life cycle of the product. I would recommend an amendment and describe the results in the FSR, as an appendix. Since this is a GLP study, you should also confer with the study director and see what their recommendation is. 



    ------------------------------
    Stephanie Markey
    Associate Director
    Fraser CO
    United States
    ------------------------------

    Original Message


  • 3.  RE: Non-GLP explorations in a GLP study

    Posted 18-Jun-2023 15:11

    I wouldn't generally recommend amending a GLP protocol for post-hoc non-GLP analyses. If the data will be used to support human dose justification, it should be written up in a report of sufficient detail that any reader could understand the provenance of the data.



    ------------------------------
    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


  • 4.  RE: Non-GLP explorations in a GLP study

    Posted 19-Jun-2023 14:19

    Hi Anon,

    I agree with Stephanie. The protocol should be updated with the plan for the additional analysis. The results should be captured in a final study report or an addendum to the original report (depending if the original is signed or released). The PK/PD results should be reported, regardless if the results are good, bad or neither (expected or unexpected). This data could be important to the product profile and should be disclosed as part of the product information. 

    -Emily



    ------------------------------
    Emily Nesbitt RAC
    Director, Regulatory Affairs
    Cincinnati, OH
    United States
    ------------------------------

    Original Message


  • 5.  RE: Non-GLP explorations in a GLP study

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jun-2023 09:07
    This message was posted by a user wishing to remain anonymous

    This is a post-hoc so, you don't need to amend the protocol, the analysis should be attached as addendum if you decide to share this with the FDA. However, make sure that you also submit the rationale/objective for your post-hoc analysis only if this is critical to support your human dose justification. Else, a post-hoc is a post-hoc so from FDA perspective if its not critical, push the ignore button! 


    Original Message


Related Content