Bioequivalence and Bioavailability Forum • HC Proposed Policy on Bioequivalence Standards for HVDS

HC Proposed Policy on Bioequivalence Standards for HVDS [Regulatives / Guidelines]

posted by d_labes – Berlin, Germany, 2015-07-02 11:19 (4014 d 06:14 ago) – Posting: # 15015
Views: 10,551

Dear Kotu,

THX for that link.

Interesting! EMA approach but allowed for AUC. Since Cmax doesn't need a CI criterion at all, only a point estimate restriction is imposed.

—
Regards,

Detlew

Complete thread:

HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05 [Regulatives / Guidelines]
- HC Proposed Policy on Bioequivalence Standards for HVDSd_labes 2015-07-02 09:19
- Bloody partial replicate again Helmut 2015-07-02 13:20
  - Bloody partial replicate again Lucas 2015-07-02 13:35
    - Which model? Helmut 2015-07-02 16:41
      - Which model? Lucas 2015-07-02 18:06
- HC Proposed Policy on Bioequivalence Standards for HVDS drgunasakaran1 2015-07-02 17:08
  - AUC and Cmax Helmut 2015-07-02 17:37
- HC for HVDs d_labes 2015-07-03 08:21
  - HC for HVDs Helmut 2015-07-03 11:55
    - Rounding d_labes 2015-07-03 12:53
      - Acceptable difference (BE history) Helmut 2015-07-03 14:49
    - Off topic ElMaestro 2015-07-03 13:02
      - Playing around with α (not exactly brilliant) Helmut 2015-07-03 15:38
        
        Playing around with α (not exactly brilliant) ElMaestro 2015-07-03 16:35
        
        Playing around with α (not exactly brilliant) Helmut 2015-07-03 16:44
        
        OT – Philosophers on duty d_labes 2015-07-03 21:11