Stock solutions for CCs and QCs [Regulatives / Guidelines]
❝ Referring to ICH guideline M10 on BA method validation step2b …
Not new. Similar in the EMA’s guideline of 2011 and the FDA’s guidance of 2018.
❝ Can you explain how separate stock solution can avoid biased estimations?
If you screw up in preparing either the stock solution for calibrators or QCs, likely many batches will fail.
❝ and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?
If you use different ones, you demonstrate that you can utilize the analytical balance, volumetric flasks, and pipettes properly.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
The quality of responses received is directly proportional to the quality of the question asked. 🚮