Bioequivalence and Bioavailability Forum

Dear all,

Well, that's not the fist time they do this while a topic is being discussed at ICH level (marking their territory ? Trying to give more strength to their positions during negotiations ?). Anyway, the FDA have published last week two new final guidances:

- Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA: see here

- Statistical Approaches to Establishing Bioequivalence: see here.