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 09:41 (424 d 10:29 ago) – Posting: # 21274
Views: 3,402

Hi ElMaestro,

Thanks ElMaestro,

» This could be a case of BE being present in males and not in females....

In fact that's the case in the pilot. Please let me know what specific data you need?

Cheers,
SKM

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

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 Genericping4santosh 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