Only for QCs; encouraged ≠ required [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2020-08-01 16:13 (961 d 18:26 ago) – Posting: # 21816
Views: 5,006

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

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

Complete thread:

UA Flag
 Admin contact
22,546 posts in 4,721 threads, 1,608 registered users;
22 visitors (0 registered, 22 guests [including 6 identified bots]).
Forum time: 09:40 CET (Europe/Vienna)

Science is the great antidote to the poison
of enthusiasm and superstition.    Adam Smith

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