Bioequivalence and Bioavailability Forum

SABE or Normal BE? [RSABE / ABEL]

posted by jag009  – NJ, 2013-02-20 16:20 (4450 d 21:00 ago) – Posting: # 10079
Views: 12,248

Hi Luvbloom

❝ Looks like you need a cup of strong black coffee.

❝ I was mentioning about page 3 of warfarin sodium guideline.

Yeah was drinking Dunkin Donut coffee and not my fav Starbuck espresso (Still not good stuff but comparatively better)

❝ ❝ FDA wants you to compare the intrasubject variation between test and reference which full replicate will give. Reason is that the difference needs to be minimal since the product is a NTI.

❝

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

Wouldn't that be wonderful then? I don't think the agency will care, or give you a medal for that. They just want to make sure that your product is not worst

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