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AI-ready · Judgment

You asked an AI assistant to summarize the stability data section for an ANDA submission and it cited an ICH guideline that doesn’t actually apply to the dosage form. How would you catch that before it goes to regulatory affairs for filing?

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My rule for anything headed into a submission is that every citation and every data claim gets traced back to source before it leaves my desk, regardless of how confident the draft reads.…

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