Repeat based on ISR data investigation [Bioanalytics]

posted by Mithu – India, 2018-08-08 10:09  – Posting: # 19160
Views: 1,081

Dear Members,

kindly share your thoughts on Repeat analysis based on the ISR data. During ISR sometimes we found that all the selected samples from any specific subject get failed to meet the acceptance criteria and failing with the huge margin with some specific trend i.e. positive or negative.

In such cases, scientists use to go for the investigation and run same samples of ISR again to find out the reason for the failure. During investigation they get the same values which they had got at the time of ISR analysis and not matching with the initial analysis.

Based on this they conclude error in the first/ initial analysis and they reject the original batch which was otherwise technically passing the batch acceptance criteria.

After going for repeat analysis of whole batch sometimes may change the outcome of the study when study passes or fails on border.

If the study gets failed then it would be a problem for a filer and if we ignore result of the ISR from which the investigation is triggered then expecting that some day agency may ask for root cause for the failure in ISR and doubt on the initial analysis.

please share with us your experience or any suggestion to handle such situations.

Regards,

Mithu

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,299 posts in 4,101 threads, 1,316 registered users;
online 14 (3 registered, 11 guests [including 6 identified bots]).

I have no opinion about ‘incurred samples’ –
an expression which has no easily understandable
meaning for me in the English language.    Nick Holford

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5