Announcements

  • June 8 Stability : CMC Stats Quarterly Joint Discussion Meeting

    By: Lori McCaig Lori McCaig , 2 years ago

    Agenda

    • Overview of Accelerated Stability Study Modelling Strategies – Stan Altan and Bill Porter
    • Uses of Accelerated Stability Data in the Large Molecule Modality – Dan Willingmyre
    • Discussion Topics
      • Topic 1:
        • What challenges have you encountered, scientific or regulatory, in the use of accelerated stability testing to support product shelf-life assignment?
        • What are the regulatory hurdles in using accelerated stability studies to support a filing?
        • What experiences have you had supporting expiry at the long-term condition by modelling accelerated data? 
      • Topic 2:
        • What are the common designs you use for accelerated stability testing?
        • Is it related to stage of product development (early, mid, late)?
        • Do you have a set of “standard” designs?
      • Topic 3
        • What other scientific questions can you address with accelerated stability testing?
      • Topic 4
        • What challenges have you had with leveraging accelerated stability testing to support stability profile comparability assessments after process or formulation changes?
      • Topic 5
        • How do you leverage accelerated stability data to support temperature excursions, supply chain handling and patient convenience allowances?