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Sep 12, 11:30 AM PT - AAPS Stability & Stats Joint Quarterly Meeting on Comparability

  • 1.  Sep 12, 11:30 AM PT - AAPS Stability & Stats Joint Quarterly Meeting on Comparability

    Community Leadership
    Posted 09-09-2024 19:27

    Dear All,

    A reminder about our joint meeting this Thursday, Sep 12th,  11:30 am PT - 1 pm PT (2:30 PM -4 pm ET). Dan, Aili and Jianfang will be leading the important topic of Comparability and enable discussion on aspects such as:

    • clinical / late-stage and commercial, 
    •  compare and contrast the different phase appropriate comparability approaches as the stability dataset increases in power
    • Establishing comparability evaluation criteria
    •  number  of control/comparator batches. 3 or more?
    • Use of Bayesian statistics?
    • Compared stress deg rates of pre-change and post-change

    Thanks 

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    Vinaya Kapoor, PhD
    Head, Regulatory Affairs CMC
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  • 2.  RE: Sep 12, 11:30 AM PT - AAPS Stability & Stats Joint Quarterly Meeting on Comparability

    Community Leadership
    Posted 09-11-2024 14:15

    Thanks for the reminder, Vinaya.

    Aili Cheng and Jianfang Hu have two excellent presentations / discussions planned around clinical and commercial stability comparability.  I am looking forward to the meeting this week!

    Dan



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    Dan Willingmyre
    Vir Biotechnology, Inc.
    Associate Director, Stability & Data Analytics

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message