Bioequivalence and Bioavailability Forum • Underrepresentation of female subjects in BE study to register Generic

Underrepresentation of female subjects in BE study to register Generic [Regulatives / Guidelines]

posted by ping4santosh – India, 2020-03-11 16:37 (2297 d 18:05 ago) – Posting: # 21253
Views: 8,007

❝ Where do you intend to submit your data ? USA: the FDA wants males and females. Europe: EMA accepts studies in males only, but "we fear that we may fail if we include females" will not be an acceptable rationale.

Dear Ohlbe,

Thanks you your response. The pilot was not powered. Pivotal is powered given the high ISCV. We didn't pre-plan it in the pilot. We took M:Fe in the ratio of 2:1 and this is a post hoc analysis. We saw high ISCV and lower Cmax in Females as compared to Males. We intend to submit the data in EU but I won't be surprised if the management decides to submit that data in FDA at a later date.

Should you suggest me to go ahead with same M:Fe::2:1 ratio for a powered pivotal?

Cheers, SKM

Complete thread:

Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 14:35
- Underrepresentation of female subjects in BE study to register Generic Ohlbe 2020-03-11 15:07
  - Underrepresentation of female subjects in BE study to register Genericping4santosh 2020-03-11 15:37
    - Study planning 101 Helmut 2020-03-11 16:31
- Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-11 15:24
  - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 16:15
    - Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 09:27
      - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:41
        
        Underrepresentation of female subjects in BE study to register Generic ElMaestro 2020-03-15 10:23
        
        Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-16 09:13
        
        Not enough subjects to say Ohlbe 2020-03-15 19:28
        
        Not enough subjects to say ping4santosh 2020-03-16 09:03
- Underrepresentation of female subjects in BE study to register Generic jag009 2020-03-15 07:30
  - Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-15 09:43