Bioequivalence and Bioavailability Forum • A strange question from my formulator friends

A strange question from my formulator friends [Regulatives / Guidelines]

posted by jag009 – NJ, 2013-08-05 17:38 (4712 d 22:07 ago) – Posting: # 11205
Views: 2,218

Hi Luvbloom,

❝ Approaching FDA, with a BE results using two or 3 lots of a reference product (same country, same product, just a different batch/lot) where even if your product is BE to all except one is futile.

Well I guess it was a good question...
Yes but what if the reference lot that you fail BE to also fails against the other reference lots?

John

Complete thread:

A strange question from my formulator friends jag009 2013-08-03 23:23
- A strange question from my formulator friends luvblooms 2013-08-05 06:22
  - A strange question from my formulator friendsjag009 2013-08-05 15:38