ICH guideline M10 on BA method validation [Regulatives / Guidelines]

posted by paulhurleyuk – NE UK, 2022-05-05 13:47 (277 d 17:52 ago) – Posting: # 22962
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❝ Can you explain how separate stock solution can avoid biased estimations? and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?


If you just used one weighing, and weighed too little material you would decrease the signal to noise, and potentially make the assay appear less precise/accurate. Conversely weighing too much material would increase signal to noise and make the assay appear more precise. Having two weighing's makes it more likely to spot that issue.

Paul.

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