Bioequivalence and Bioavailability Forum

Hi sushil.pimpare,

❝ 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?

After ISR investigation? Perhaps I get your question wrong but I am leaning towards a no. You usually use the original one for PK and stats, unless you have a root cause. The ISR value is typically used for ISR purpose only.
Note also that if you have a root cause it will sometimes -though not always- imply that more samples than just the ones used for ISR need a re-analysis.

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.