Bioequivalence and Bioavailability Forum

Dear Lechia,
I have a little bit different view than Helmut and ElMaestro.

❝ All things considered I think it is reasonable to write in the protocol that you will consider the result a kind of pivotal proof if you show BE, and then an assessor can later decide if (s)he likes that or not.

IMHO pilot BE studies are Proof-of-Concept studies performed with a formulation that might be used for producing validation batches of which one will usually be used to demonstrate BE, i.e. the formulation you use in a pilot study is produced in lab scale and not in commercial scale and can therefore not be used for a pivotal study. Once you got the pilot study results and decided the formulation is o.k. you scale up. If you already have produced validation or commercial scale batches of your formulation you must be pretty sure that this formulation is bioequivalent. So if I you now run a pilot study one could get the impression that you aim at bioequivalence in a first try with a cheap study and still reserve the option for a second try to run a "second pivotal" study.
You should also consider the number of subjects. Usually the number for a pilot study is low (e.g. 12 subjects). If you have a variable drug and power a "pilot" study in such a way that it might become bioequivalent an assessor might become distrustful. The same applies if you need the pilot study for the estimation of variablity. In this case you should think of a two-stage design for a pivotal study.
Kind regards
Dr_Dan