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Pharmaceutical Stability Study Data Aggregator and ICH Q1A Shelf-Life Calculator via Notion for Case Review Change-control Review for Cross-Functional Rollout Scenario 0616

Aggregate stability data from accelerated and long-term ICH Q1A stability studies for a small molecule API and calculate shelf-life using linear regression with 95% confidence bounds per FDA guidance.

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• Biotechnology & Life Sciences
• Pharmaceutical Development & Regulatory Affairs

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