Bioequivalence and Bioavailability Forum

SABE or Normal BE? [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2013-02-20 17:08 (4450 d 16:47 ago) – Posting: # 10081
Views: 12,197

Hi Helmut, Luvblooms and others,

❝ ❝ Just a thought, What if the variability in the reference product is higher than test?

❝

❝ Wouldn’t matter since variabilities are compared by a one-sided test. In other words, the variability of the test must not be significantly larger than the one of the reference. Smaller is fine.

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.
Food for thought for those who blindly keep repeating their mantras that generics are just always worse than their innovator counterparts. Oddly enough there's an high percentage of these peope in innovator companies

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