Bioequivalence and Bioavailability Forum

Dear Joy!

❝ Would you know where innovator companies conduct their BE studies? I have come across several BE studies (in addition to BA) done by innovator companies submitted as part of the NDA application but there was no mention of the BE testing center. Do they do it in-house or avail of the facilities and services of a Clinical Research Organization?

Innovators have to perform BE studies if they are changing their formulations during product development (e.g., going from formulations used in the first clinical studies to formulation intended for marketing).
They do their studies both in-house and at external CROs.
As a general rule they show more trust in larger, well-established CROs - in small CROs they may be suspicious of some kind of 'information leaking'
As seen from a medium-sized CRO's (20 BE studies/year) perspective, I would estimate only ~5% of BE studies performed sponsored by innovators (although the percentage may be somewhat higher if you include food- and PK-interaction studies as well).