Bioequivalence and Bioavailability Forum

Dear Srinivas,

❝ As per EMA's BMV Sec 6:"It is therefore recommended to evaluate accuracy of incurred samples by reanalysis of study samples in separate runs at different days". So doesn't this mean that they have to be run in separate batches and the ISR be performed on diffrent day?

My understanding is that each sample needs to be reanalysed in a separate run and on a different day from the initial analysis, not from any other analysis.

❝ I have come across a regulatory inspector who insisted that repeats samples be run in seperate batches.

From which authority ?

❝ The inspector insisted that even though there was a single repeat in the entire study this cannot be clubbed with subject samples although properly named and has to be repeated in a separate batch.

Did he give any explanation or justification for this requirement ?