Bioequivalence and Bioavailability Forum • Bloody partial replicate again

Bloody partial replicate again [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-07-02 15:20 (4009 d 08:18 ago) – Posting: # 15017
Views: 10,320

Hi Kotu,

THX for the information.

Why the heck:

The test product (T) should be administered either once in a 3-period design (RTR, TRR, RRT) or twice in a 4-period design (TRTR, RTRT).

No full replicate 3-period design (TRT|RTR)? See this lengthy thread. Disappointing.

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Complete thread:

HC Proposed Policy on Bioequivalence Standards for HVDS balakotu 2015-07-02 09:05
- HC Proposed Policy on Bioequivalence Standards for HVDS d_labes 2015-07-02 09:19
- Bloody partial replicate againHelmut 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

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