Bioequivalence and Bioavailability Forum

Re-dosing [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-02 16:44 (4711 d 06:05 ago) – Posting: # 11168
Views: 30,549

Hi John,

❝ ❝ Do you have a reference? If I recall it correctly the sample size should be six or 20% of subjects – whichever is larger. 26 ≠ small, IMHO. ;-)

❝

❝ 26 < 124. You know what I mean by small (relative wise)...

You noted the irony smiley? Of course if one is used to run studies in 100+ subjects 26 are peanuts.

❝ I need to dig up that particular report of mine (not mine, someone ran it before my time).

Yes, please. AFAIK, the redosing sample size was never an official recommendation by the FDA. I have seen it in a few documents under FOI. Maybe I have them somewhere, but since they are all scanned PDFs no way of searching.

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Helmut Schütz

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Science Quotes

Complete thread:

AUCextrap more than 20% sam 2013-08-01 06:15
- AUCextrap more than 20% ElMaestro 2013-08-01 10:29
  - AUCextrap more than 20% sam 2013-08-01 11:21
    - AUCextrap more than 20% ElMaestro 2013-08-01 11:39
      - AUCextrap more than 20% sam 2013-08-01 12:01
        
        AUCextrap more than 20% Helmut 2013-08-01 12:52
    - forced BE d_labes 2013-08-01 11:59
      - Gambling ♠ ♣ ♥ ♦ Helmut 2013-08-01 13:31
- AUCextrap more than 20% Helmut 2013-08-01 12:32
  - AUCextrap more than 20% sam 2013-08-01 12:55
    - 46% power in study planning? Helmut 2013-08-01 13:18
      - 46% power in study planning? sam 2013-08-01 13:40
        
        46% power in study planning? jag009 2013-08-01 20:04
        
        Re-dosing Helmut 2013-08-02 03:32
        
        Re-dosing jag009 2013-08-02 05:10
        
        Re-dosingHelmut 2013-08-02 14:44
        
        46% power in study planning? sam 2013-08-02 07:00
        
        Carved in stone? Helmut 2013-08-02 03:22
        
        Carved in stone? sam 2013-08-02 07:02
        
        Carved in stone? luvblooms 2013-08-02 08:37
        
        Carved in stone? sam 2013-08-02 09:01
        
        Ethics (again) Helmut 2013-08-02 14:53
        
        Update jag009 2013-08-02 17:25
        
        Update Helmut 2013-08-02 18:11
        
        Update jag009 2013-08-02 20:11
        
        Outliers (CAN) Helmut 2013-08-02 20:56
        
        Outliers (CAN) jag009 2013-08-02 22:23
        
        OT: Expert Helmut 2013-08-03 10:11
        
        Update jag009 2013-08-02 22:29
        
        Update ElMaestro 2013-08-02 23:08
        
        Update jag009 2013-08-03 23:00
        
        Update luvblooms 2013-08-05 06:02
        
        Update jag009 2013-08-05 20:14

Re-dosing [Study As­sess­ment]

Complete thread:

Re-dosing [Study Assessment]