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Robust Stability Protocol for CMC Submissions
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The podcast episode explores the development of robust stability protocols for Chemistry, Manufacturing, and Controls (CMC) submissions within New Drug Applications (NDA) or Biologics License Applications (BLA). It emphasizes aligning stability protocols with regulatory guidelines from bodies like the FDA and EMA, focusing on key aspects like study design, storage conditions, analytical method validation, quality control, and forced degradation studies. The episode also highlights the need for data integrity, clear scope definition, and container compatibility, underscoring how a strong stability protocol ensures drug quality, safety, and efficacy throughout its shelf-life, supporting successful NDA/BLA submissions.
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