Bioequivalence and Bioavailability Forum

RSABE [Regulatives / Guidelines]

posted by Lucas – Brazil, 2014-03-24 18:05 (4481 d 09:16 ago) – Posting: # 12694
Views: 13,522

Hello.

❝ Gives an opportunity to clarify whether

• FA0(1) instead of FA0(2) might be used in evaluating the partial replicate design (due to convergence issues with the latter if unscaled ABE has to be applied) or
  

  ❝

• a fully replicated three-period design (i.e., TRT|RTR) is an acceptable alternative.

I’m struggling with this scaled BE, especially with FDA’s method. There are some papers that state that the acceptance range would be scaled based on the reference within subject variability, but the CI for the GMR would be obtained the same way as in ABE (similar to EMA’s ABEL). Others state that the criteria would not be expand the limits, but to use a “Howe method” that I haven’t quite understand yet. FDA's draft guidance from dec 2013 is not clear on that.

Can anybody help me clear that up?

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
      • RSABELucas 2014-03-24 17:05
        • RSABE Helmut 2014-03-24 17:25
          • RSABE Lucas 2014-03-25 13:33
            • RSABE Helmut 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