Bioequivalence and Bioavailability Forum

Hola all,

I am chewing my way through some meeting transcripts from FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.
This makes great reading Perhaps the topic isn't one you'll entertain auntie Betty with during a family dinner, but it does shed some info on how difficult it is to get consensus on single issues within agencies. And since the topic of most of those meetings relates to BE, it is a quite useful read, simply.

Anyone who's got time and interest in reading hundreds of pages of argumentative transcripts, or who can't understand why making guidelines is such a daunting task, should read them.
Example here.

Note how much time they spend on debating definitions (e.g. the term "small") before they actually get any voting done.

Some highlights (please care to get the context by actually opening the link):
Page 332: "DR. YU: This is just arithmetic; it is not geometry". Yup, nerves get a little worn sometimes.

Page 306: "MEMBER KIBBE: Okay. Whenever I think that we come up with a solution, we should have a solution to a real problem and not the perception that there might be a problem." (When I read that I could not help thinking about Incurred Sample Re-analysis )

Page 276: "MEMBER KOCH: I was guess I was going to maybe ask a question or make a suggestion that perhaps one of the options in voting is, yes, with the suggested changes.
CHAIR TOPP: I don't know that there is a button for that. So, we may have a little trouble with "yes, but". The "yes, but" button, I don't think we have one of those".


Have a good weekend.