Bioequivalence and Bioavailability Forum • ANVISA’s home brewed scaling?

ANVISA’s home brewed scaling? [RSABE / ABEL]

posted by ElMaestro – Denmark, 2015-05-28 21:10 (3580 d 19:50 ago) – Posting: # 14878
Views: 9,870

Hi Helmut,

❝ […] in the cases that the intra-subject coefficient of variation (CV%) exceeds 40% for the originator product.

Haha, for a moment I thought you were serious. But then realised that of course no agency will be enforcing such a weird and unjustified requirement.

You almost had me there. Great sense of humour.

—
Pass or fail!
ElMaestro

Complete thread:

ANVISA’s home brewed scaling? Helmut 2015-05-28 18:27 [RSABE / ABEL]
- ANVISA’s home brewed scaling?ElMaestro 2015-05-28 19:10
  - ANVISA: TIE, sample size Helmut 2015-06-02 16:00
    - ANVISA: scABEL TIE d_labes 2015-06-03 11:59
      - ANVISA: scABEL TIE Helmut 2015-06-03 12:07
        
        ANVISA: scABEL TIE part II d_labes 2015-06-03 13:19
        
        ANVISA: scABEL TIE part II nobody 2015-06-03 13:31
        
        ANVISA: scABEL TIE part II d_labes 2015-06-03 14:00
        
        ANVISA scABEL - sample size d_labes 2015-06-05 11:03
- ANVISA’s home brewed scaling? Lucas 2015-06-02 16:02
  - ANVISA’s home brewed scaling? Helmut 2015-06-02 16:16