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.