Stock solutions for CCs and QCs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-05-04 14:48 (23 d 03:37 ago) – Posting: # 22960
Views: 269

Hi PSU,

» 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. :-D
—
Dif-tor heh smusma 🖖 [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,108 posts in 4,630 threads, 1,567 registered users;
online 5 (0 registered, 5 guests [including 2 identified bots]).
Forum time: Friday 18:26 CEST (Europe/Vienna)

We absolutely must leave room for doubt
or there is no progress and no learning.
There is no learning without having to pose a question.
And a question requires doubt.
People search for certainty.
But there is no certainty.    Richard Feynman

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