Only for QCs; encouraged ≠ required [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2020-08-01 16:13 (853 d 09:21 ago) – Posting: # 21816
Views: 4,813

Hi dshah,

❝ If we consider the recent FDA guideline or ICH M10, i believe trend analysis for IS response, CC and QCs is also required.


Only for QCs and not required but encouraged (FDA page 30, ICH page 46).
However, Shuanghe’s batch passed the criteria and hence, possibly we will not see any trend of back-calculated concentrations. But of course, the shift in IS-responses is obvious.

@Shuanghe: Can you send me a file (CSV preferred) by PM with this columns?

injection, type of sample (containing B, Q, C, U), back-calculated concentration, IS response

I will upload it to have sumfink to play with. Bland-Altman plots might be an option. An idea: Set limits based on the one batch of the method validation which was performed in the anticipated maximum size of a run. If you have data of this batch, please give it as well.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [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
22,426 posts in 4,694 threads, 1,600 registered users;
12 visitors (0 registered, 12 guests [including 7 identified bots]).
Forum time: 00:35 CET (Europe/Vienna)

The rise of biometry in this 20th century,
like that of geometry in the 3rd century before Christ,
seems to mark out one of the great ages or critical periods
in the advance of the human understanding.    R.A. Fisher

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