Bioequivalence and Bioavailability Forum

Hi Osama,

good point!

❝ Are there any regulations,Guidlines regarding to how long is a BE study valid?

Not that I recall. I once suggested a “shelf-life” for BE-studies at a conference and the following discus­sion was, well, lively. Even members of EMA’s PKWP didn’t see any reason to reject and “old but good” study.
OK, but can a fifteen year old study realistically conform to current standards? Mine don’t.
Practically EMA “tagged” studies which were performed before February 2012 if ISR is missing. There are some ways out, which are described in the Q&A-document, Section 13.
Experiences here and there.

❝ I mean, if a study is conducted, say 2001, and was applied to registered at this time, could the manufacture apply with the same study on 2014 for another regulatory agency?

Sure. I know one company which at an amazing rate submits studies I have performed for them in the last century to Middle Eastern agencies… Must be fun to review them.