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Judgment & ambiguity · Calibrating confidence

Your assay validation shows acceptable accuracy and precision, but the qualification was run on a single reagent lot. A colleague asks whether you'd stake a go/no-go program decision on results from this assay. How sure are you, and what do you say?

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I'd say I'm confident in the assay's performance on the conditions I tested, and explicitly not yet confident in its robustness — and that distinction is the whole answer.…

The full answer: structure, worked example, likely follow-up.

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