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  • 1.  PK SAMPLING STORAGE TIMES

    This message was posted by a user wishing to remain anonymous
    Posted 17-Nov-2021 10:47
    This message was posted by a user wishing to remain anonymous

    Hello RAPS members!

    Could you please confirm how long PK samples should be stored? What is the regulatory basis for this time? 
    We are going to file a submission, and are currently working on the contract with CRO. We would like to include this in the contract. 
    Currently CRO propose:  "PK Sample storage for 3 months at no cost after draft report is shared with sponsor".
    Is that time OK from a regulatory perspective?
    Thanks!


  • 2.  RE: PK SAMPLING STORAGE TIMES

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2021 17:02
    This message was posted by a user wishing to remain anonymous

    2 years. check CFR or hire a RA professional, these are not major issues!
    Original Message


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