Bioequivalence and Bioavailability Forum

Hi El maestro,

Thank you for your clear explanation!

So if I understand well, the best way to justify the scaling is to perform a "classical" replicate design i.e using the same batch administered two times to the same subject and I agree with it to avoid some bias in the statistical analysis (in particular within subject variability forced).

Furthermore, as I mentioned in a previous post the rationale to use two different batches of the reference product is to demonstrate that the reference product is variable from batch to batch and maybe not BE between them. The idea was to take two batches presenting two different profile in-vitro (opposite profiles but still within the specifications) resulting in two different PK profile. What do you think about this method?

Thank you and have a good day¨!

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]