Bioequivalence and Bioavailability Forum • SABE or Normal BE?

SABE or Normal BE? [RSABE / ABEL]

posted by jag009 – NJ, 2013-02-21 18:10 (4503 d 18:19 ago) – Posting: # 10093
Views: 12,348

Hi guys,

❝ I think it is actually quite common to see the ref-variability exceeding that of the test. While I am no CMC expert I think the originator company's production lines are often 20+ years old, while the generic company's production lines are new. And hence tablet-to-tablet variation is oftentimes better controlled by the generic company and this accounts to some degree for the observed difference in intra-subject CV's.

Just curious (or lazy). Has FDA ever published (or presented) data of withinsubject CV from test and reference from submitted full replicate studies?

John

Complete thread:

SABE or Normal BE? luvblooms 2013-02-19 05:07 [RSABE / ABEL]
- FDA: rSABE for NTIDs Helmut 2013-02-19 11:05
- SABE or Normal BE? jag009 2013-02-19 15:23
  - Sample size? Helmut 2013-02-19 17:25
  - SABE or Normal BE? luvblooms 2013-02-20 05:26
    - SABE or Normal BE? jag009 2013-02-20 15:20
    - SABE or Normal BE? Helmut 2013-02-20 15:45
      - SABE or Normal BE? ElMaestro 2013-02-20 16:08
        
        SABE or Normal BE?jag009 2013-02-21 17:10
        
        FDA’s example data sets Helmut 2013-02-21 17:18
        
        FDA’s example data sets jag009 2013-02-21 20:14
        
        FDA’s example data sets Helmut 2013-02-21 22:42
        
        FDA’s example data sets jag009 2013-02-22 15:46
        
        FDA’s example data sets Helmut 2013-02-22 16:33