An example of IS response. Need your helps. [Bioanalytics]

posted by Shuanghe  – Spain, 2020-05-26 18:32 (1452 d 15:01 ago) – Posting: # 21476
Views: 8,399

Dear Sukalpa,

Many thanks for your comments.

❝ ...The criteria fulfilled because the response of IS in CC and QC increased along with study samples, as per SOP.

❝ ...

❝ But personally speaking, I have come across this type of scenarios in the past. But possibilities of the change in concentrations are less, because we determine concentrations based on the area ratio.

I don't doubt that the run fulfill certain criteria with certain nemerical values according to CRO's current SOP. What I'm not comfortable about is the fact that runs like this, with such obvious trends of response deviation, were not investigated. It's more about the studies in future instead of the past.

❝ Looking at the data, I think the response of IS and analyte increased proportionally as the QC samples are passed resulting a successful analytical run.

Well, with the above figure in fornt of me, I wouldn't say this was a seccessful run just because it pass certain numeric values defined in the current SOP. Given the example like this happened, I would rather question if the current SOP is reasonable enough.

All the best,

Complete thread:

UA Flag
 Admin contact
23,029 posts in 4,834 threads, 1,641 registered users;
36 visitors (0 registered, 36 guests [including 4 identified bots]).
Forum time: 09:33 CEST (Europe/Vienna)

The most erroneous stories are those we think we know best–
and therefore never scrutinize or question.    Stephen Jay Gould

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