Incurred sample reanalysis [Regulatives / Guidelines]

posted by Ohlbe – France, 2017-06-06 14:10 (2804 d 15:48 ago) – Posting: # 17450
Views: 4,255

Dear Sushil,

Please follow the forum policy when posting, particularly under "Be polite".

❝ After ISR investigation (for the samples those are having % difference more that 50 %), Can we report and consider ISR value for PK and Stat analysis if it is mentioned in the SOP?


I agree with ElMaestro. Using the ISR result may not be accepted and should only be considered if:
- you have identified a root cause for the deviation. I mean a real root cause, not just something like "the analyst may have made a mistake when processing the sample"
- you can identify all samples affected by this same root cause and re-analyse them. Meaning, not just those already re-analysed for ISR and where you found a large difference.

One example could be a situation where the analyst failed to react on internal standard response deviation. You could go back to the raw data, identify all samples with IS deviation and re-analyse them.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,376 posts in 4,912 threads, 1,665 registered users;
144 visitors (0 registered, 144 guests [including 5 identified bots]).
Forum time: 04:59 CET (Europe/Vienna)

There are sadistic scientists who hurry to hunt down errors
instead of establishing the truth.    Marie Curie

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