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

posted by paulhurleyuk – NE UK, 2022-05-05 11:47 (145 d 11:52 ago) – Posting: # 22962
Views: 510

» 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.


Complete thread:

UA Flag
 Admin contact
22,391 posts in 4,685 threads, 1,595 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time: Tuesday 23:40 CEST (Europe/Vienna)

Statistics. A sort of elementary form of mathematics which consists of
adding things together and occasionally squaring them.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz