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  • 1.  in vivo potency testing for batch release

    This message was posted by a user wishing to remain anonymous
    Posted 10-Feb-2022 15:45
    This message was posted by a user wishing to remain anonymous

    Hi all,

    I would have a question regarding the in vivo potency testing performed for the batch release.
    The experiment consists of 2 parts: 1) the in life part in mice and 2) analysis of the mice derived samples. Part 2) is done under GMP and is the value reported in the specifications/CoA.

    My question is related to part 1) in life part in mice.  What are the quality standards to be applied, is GLP mandatory?
    Could you please provide any guideline as reference (EU, US)?

    Thank you very much!


  • 2.  RE: in vivo potency testing for batch release

    Posted 11-Feb-2022 07:13

    Hi there
    Refer 21 CFR 58, and  OECD monographs will give you information, how you can be GLP compliant for the animal data used for in vivo potency.



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    Pallavi Sharma
    Florham Park NJ
    United States
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