Bioequivalence and Bioavailability Forum

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