Bioequivalence and Bioavailability Forum

Update [Study As­sess­ment]

posted by luvblooms  – India, 2013-08-05 08:02 (4704 d 13:40 ago) – Posting: # 11196
Views: 30,242

Dear John

❝ Original fasting study was n=47, rechallenge was n=8 with 5 questionable subjects + 3 controls; The 5 questionable subjects were suspected as outliers because their Cmax ratios were greater than ± 2 standard deviations from the mean ratio. AUCs were fine. All subjects were from the original study population. The rechallenge study was successful so the original study data was re-evaluated with n=42 (minus the 5 weirdos) and bioequivalence was concluded. How did we conclude that the 5 weirdos were enigmatic? Well their ratio observed from the rechallenge study were within ± 2 SD of the mean observed from the original study. Note that this assessment was made for Cmax and AUCs ratios.

Shouldn't it be Mean ± 3 SD as per the 68–95–99.7 rule or three-sigma rule or empirical rule????

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-dosing Helmut 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
                      • Updateluvblooms 2013-08-05 06:02
                        • Update jag009 2013-08-05 20:14