Bioequivalence and Bioavailability Forum

FDA: rSABE for NTIDs [RSABE / ABEL]

posted by Helmut  – Vienna, Austria, 2013-02-19 12:05 (4506 d 00:02 ago) – Posting: # 10054
Views: 12,908

Dear Luv!

❝ […] I found something which left me drooling

Glycopyrronium bromide may help.

❝ a) Now in view of these lines, does a full replicate study is really going to help any sponsor in getting widening or still need to follow 80-125?

Narrowing – not widening. See this post/followings and this presentation.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• SABE or Normal BE? luvblooms 2013-02-19 05:07 [RSABE / ABEL] 
  • FDA: rSABE for NTIDsHelmut 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