Bioequivalence and Bioavailability Forum

❝ Larger than what?

Larger then needed from expected variability. if observed variability gives samples size around 48 than can we take more than that i.e. around 60.

❝ Only in a few cases of BCS class II drugs (under certain conditions) there is an in vivo in vitro correlation. For BCS class IV drugs never. You plan the study always based on the in vivo variability and T/R-ratio for a desired power. In other words, BCS does not play any role.

Here the case is, we are dealing with some technology transfer products in which we could not change our test formulation which was meet the BE marginally at the time of initially filing. now due to this bottle neck, our thinking is if we take little large sample size, than we can manage variability (my expectation may be not correct).

Hope I could place my point correctly.

Regards,

Mithu

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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]