Bioequivalence and Bioavailability Forum • Two-stage or RSABE

Two-stage or RSABE [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2013-12-08 14:59 (4588 d 10:58 ago) – Posting: # 12020
Views: 20,899

Dear Dr. Gunasakaran!

❝ For applicants wishing to use variations of these study designs or analysis methods (e.g., a sequential design or scaled-average BE, we recommend that you submit a complete protocol for review and comment before starting the study."

Thanks for pointing that out (lines 125-127); it slipped through my attention. Apart from a potential delay – any recent experiences from our members how long the review process at the FDA takes? – I’m really fine with that.

Sequential designs
I’m positive about the acceptance of Potvin’s Method C and its derivatives. FDA’s CDER cosponsored PQRI’s studies and FDA’s Donald Schuirmann is one of the authors; these are the variants they recommended (not Method B!). See also product-specific guidances on Loteprednol Etabonate / Tobramycin (06/2012) and Loteprednol Etabonate (04/2013).
RSABE
Gives an opportunity to clarify whether
- TYPE=FA0(1) instead of TYPE=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.

—
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Helmut Schütz

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Science Quotes

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 RSABEHelmut 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
        
        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