Bioequivalence and Bioavailability Forum • data adopted in simultaneous analysis

kanonpia
☆

Korea,
2009-07-17 12:56
(6183 d 20:19 ago)

Posting: # 3962
Views: 3,229

data adopted in simultaneous analysis [Bioanalytics]

Dear All

I would like to know you experience or some guideline.

This study is measured by two compounds (A and B). it was happened QC fail in B compound. so, we re-analysed two compounds in next day.
My question are
1) A: How should we adopt firstday data or second data?
2) if two data (first day data and second day data) are very different, Which data should we adpot?

Please share your experience and knowledge.
Thanks

Best regards,

Ohlbe
★★★

France,
2009-07-17 13:23
(6183 d 19:52 ago)

@ kanonpia
Posting: # 3963
Views: 2,547

Run validated for A, rejected for B

Post reply

Dear Kanonpia,

❝ it was happened QC fail in B compound. so, we re-analysed two compounds

❝ in next day.

❝ 1) A : How should we adopt first day data or second data?

The FDA guideline on method validation states:
Samples involving multiple analytes should not be rejected based on the data from one analyte failing the acceptance criteria.

Translation: you are supposed to report and use the data from the first run for analyte A.

❝ 2) if two data (first day data and second day data) are very different,

❝ Which data should we adopt?

If you have very different data, it means you may have a very big problem with your bioanalytical method. I would recommend you to try and understand why you have such differences, and you may need to re-develop your method and re-analyse all samples :-(

. Basically this would sound like failing "incurred sample reanalysis".

Regards
Ohlbe

kanonpia
☆

Korea,
2009-07-17 19:11
(6183 d 14:04 ago)

@ Ohlbe
Posting: # 3966
Views: 2,509

Run validated for A, rejected for B

Post reply

❝ Translation: you are supposed to report and use the data from the first

❝ run for analyte A.

Thanks,

❝ If you have very different data, it means you may have a very big problem

❝ with your bioanalytical method. I would recommend you to try and

❝ understand why you have such differences, and you may need to re-develop

❝ your method and re-analyse all samples :-( . Basically this would sound

❝ like failing "incurred sample reanalysis".

Thanks, this is my guess. it would not happen. I agree with your opinion.

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Edit: Standard quotes restored and full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]