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

posted by paulhurleyuk – NE UK, 2022-05-05 13:47 (746 d 23:11 ago) – Posting: # 22962
Views: 1,344

❝ 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:

UA Flag
Activity
 Admin contact
23,034 posts in 4,835 threads, 1,647 registered users;
26 visitors (0 registered, 26 guests [including 3 identified bots]).
Forum time: 12:58 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5