Bioequivalence and Bioavailability Forum • Warfarin Sodium 95% Upper bound criteria

Warfarin Sodium 95% Upper bound criteria [RSABE / ABEL]

posted by Nirali – India, 2019-01-30 16:38 (1586 d 12:31 ago) – Posting: # 19830
Views: 5,363

Dear Helmut,

I need the same guidance for Warfarin Sodium case.
If the 95% upper bound for Cmax parameter is 0.002, should we conclude this study as a bioequivalent for Cmax?

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

Regards
Nirali

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 criteriaNirali 2019-01-30 15:38
        
        Upper bound in RSABE ≤0 Helmut 2019-02-02 14:15
        
        Upper bound in RSABE ≤0 Nirali 2019-02-12 07:10