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Establishing Shelf-life using Accelerated Predictive Stability

  • 1.  Establishing Shelf-life using Accelerated Predictive Stability

    Community Leadership
    Posted 2 hours ago

    This presentation provides an introduction to accelerated predictive stability (APS) methodologies used to support risk-based decision-making and establish shelf-life based on short-term data. Topics include common APS approaches, sources of model uncertainty, and limitations of each approach. Case studies spanning a range of drug modalities are presented, along with literature resources for APS, including its use in regulatory filings. This presentation will be followed by ~30min Q&A.

    The presenter will be Patrick Kelleher from FreeThink Technologies on behalf of the AAPS CMC Predictive Stability working group.

    Meeting Time: 12PM (EST) / 9AM (PST) on Aug 24th. We look forward to your attendance and engagement.

    See below for meeting link.

    Microsoft Teams meeting
    Meeting ID: 446 758 067 643 46
    Passcode: zT2fW7iy
    Join on a video conferencing device
    Tenant key: [email protected]
    Video ID: 139 883 811 6
    For organizers: 19_meeting_NTZjYzI3MzQtNjkyYi00NmY2LThhMGUtM2U1ZGY5ZThhNjkz@thread.v2&messageId=0&language=en-US" target="_blank" class="x_me-email-link OWAAutoLink" rel="noreferrer noopener" data-auth="NotApplicable">Meeting options



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    Sherilyn Campie M.S.
    Director, Quality Control
    Accord Biopharma
    Raleigh NC
    [email protected]

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