Bioequivalence and Bioavailability Forum

Hi Compliance,

❝ Is it require to be administered same lot of RLD in reference scaled bioequivalence study? I also want to understand the statistics of this approach. Kindly suggest me suitable guidance document.

You do not wish to use different lots. It would confound the within-subject variance with additional between-batch variance and you could quickly end up in trouble. For example if regulators get the impression that you deliberately have tried to inflate the intra-CV in order to pass the scaling criterion.
This forum has a lot of good info on ref. scaling from practical and theoretical angles; much more than you'll find in any guidance paper.