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, 2020-03-15 10:43 (1501 d 12:29 ago) – Posting: # 21275
Views: 4,265

❝ You are trying not to use female subjects because they caused your study to fail. That alone is not a good justification.

Hi Jag,

Thanks for your suggestion. What do you think should be the ratio of M:Fe, wherein you know that more female you take, the more closer you get to bioinequivalency. Whats your take?

Cheers,
SKM

Edit: Standard quotes restored; see also this post #8. [Helmut]

Complete thread:

Underrepresentation of female subjects in BE study to register Generic ping4santosh 2020-03-11 14:35 [Regulatives / Guidelines]
- 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 Generic ping4santosh 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 Genericping4santosh 2020-03-15 09:43