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RegisterICH guideline M10 on BA method validation [Regulatives / Guidelines]
❝ 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.
Complete thread:
- ICH guideline M10 on BA method validation PSU 2022-05-03 15:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Stock solutions for CCs and QCs Helmut 2022-05-04 14:48
- ICH guideline M10 on BA method validationpaulhurleyuk 2022-05-05 11:47
Ing. Helmut Schütz