PMx Data Programming Special Interest Group
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Contains 3 Component(s) Recorded On: 01/19/2024On-Demand
This webinar discusses the ADaM sub-team's efforts in creating a CDISC ADaM standard for Population PK analysis. It addresses challenges in software compatibility and limited adoption of ADaM standards. The presentation emphasizes a BDS-like implementation for PopPK, managing differences between CDISC standards and analysis needs. The benefits of ADPPK standards are highlighted for enhancing quality, efficiency, and industry collaboration, with insights from the FDA on adoption.
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Contains 1 Component(s) Recorded On: 09/29/2023On-Demand
In this presentation the speakers highlight the updates in the latest FDA Guidance for Population PK that impact the PMx Datasets, Report and eSub aspects. They provide some discussion and recommendations on how to incorporate the changes into the submission package.
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