Bioequivalence and Bioavailability Forum

RSABE [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2014-03-25 15:31 (4475 d 05:14 ago) – Posting: # 12707
Views: 13,051

Hi Lucas,

❝ So, to expand the acceptance range based on the CVwr would not be acceptable for FDA?

I don’t think so. Why don’t you want to use their method?

❝ Please see …

I know. FDA’s Donald Schuirmann showed scaled limits in a couple of his presentations as well.

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


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Complete thread:

• Draft FDA Guidance Dec 2013 pash413 2013-12-04 15:05 
  • First impressions Helmut 2013-12-04 16:47
    • First impressions nasir 2014-02-14 06:47
  • What is Bioequivalence in the US really? ElMaestro 2013-12-07 23:34
    • Site of action vs. systemic circulation Helmut 2013-12-08 02:05
  • Draft FDA Guidance Dec 2013 drgunasakaran1 2013-12-08 08:39
    • Two-stage or RSABE Helmut 2013-12-08 13:59
      • Two-stage or RSABE ElMaestro 2013-12-08 14:17
        • Two-stage methods Helmut 2013-12-08 14:44
          • Two-stage methods ElMaestro 2013-12-08 18:56
      • RSABE Lucas 2014-03-24 17:05
        • RSABE Helmut 2014-03-24 17:25
          • RSABE Lucas 2014-03-25 13:33
            • RSABEHelmut 2014-03-25 14:31
              • RSABE Lucas 2014-03-26 15:19
                • RSABE Helmut 2014-03-26 15:28
    • Draft FDA Guidance Dec 2013 jag009 2013-12-09 22:31
      • Draft FDA Guidance Dec 2013 kvgreddy06 2014-02-14 16:44
  • End of consultation approaching‼ Helmut 2014-02-26 11:32
    • End of consultation approaching‼ wien-ui 2014-03-01 08:05
      • End of consultation approaching‼ Helmut 2014-03-01 20:09
        • End of consultation approaching‼ wien-ui 2014-03-04 10:53