Bioequivalence and Bioavailability Forum • Upper bound in RSABE ≤0

Upper bound in RSABE ≤0 [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2019-02-02 14:15 (808 d 11:41 ago) – Posting: # 19844
Views: 3,979

Hi Nirali,

» If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?

No, since the upper bound has to be less or equal to zero. No rounding here …

» There is no specific criteria given for 95% upper bound in the OGD of Warfarin Sodium.

≤0 is the general rule for the FDA’s RSABE.
See also Jay’s post above, this thread, and a paper of the two Lászlós.*

Endrényi L, Tóthfalusi L. Determination of Bioequivalence for Drugs with Narrow Therapeutic Index: Reduction of the Regulatory Burden. J Pharm Pharm. 2013;16(5):676–82. PMID 24393551. free resource.

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Complete thread:

FDA: RSABE for NTID Jay 2018-03-26 13:31 [RSABE / ABEL]
- FDA: RSABE for NTID jag009 2018-03-26 17:57
  - FDA: RSABE for NTID Jay 2018-04-02 06:28
    - FDA: RSABE for NTID pjs 2018-04-02 15:07
      - FDA: RSABE for NTID Jay 2018-04-04 14:24
        
        β = 1 – π Helmut 2018-04-04 15:03
        
        Warfarin Sodium 95% Upper bound criteria Nirali 2019-01-30 15:38
        
        Upper bound in RSABE ≤0Helmut 2019-02-02 14:15
        
        Upper bound in RSABE ≤0 Nirali 2019-02-12 07:10