Bioequivalence and Bioavailability Forum

Hi Sambasiva!

First see here, please.

❝ Is the batch repeat comes under repeat analysis percentage calculations? If yes please justify.

Yes - if an entire batch fails, you are using only the values of the repeated batch for PK, right? Therefore Nº of repeated samples = size of batch.

❝ There are some regulatories suggesting not to do more than 20% of samples under repeat analysis. (The said 20% is only individual repeats or including batch repeats?)

20% of the study's samples, irrespective of the reason (batch repeat or individual repeats like sample processing error, equipment failure, dilution of samples >ULOQ, etc.). Just my 2¢.