Bioequivalence and Bioavailability Forum

copy & paste error or what? [Study As­sess­ment]

posted by Helmut  – Vienna, Austria, 2013-07-29 13:14 (4362 d 14:43 ago) – Posting: # 11098
Views: 20,876

Dear Sam,

I don’t believe in your sample sizes. Based on your CIs, I get different ones. Still I think that you excluded subjects’ AUCs. Why?

Fed Pilot Study
                     yours             mine
Dependent      Power   CV(%)  n  “power”  CV%   n
Ln(AUCINF_obs)  51.0   32.2  14    7.88  32.3  13
Ln(AUClast)     65.0   26.3  14    5.72  26.3  13
Ln(Cmax)        41.0   37.8  14    3.42  37.9  13

Fed Pivotal Study
                     yours             mine
Dependent      Power   CV(%)  n  “power”  CV%   n
Ln(AUCINF_obs) 100.0   14.5  44  100.00  14.5  43
Ln(AUClast)    100.0   14.8  44  100.00  14.8  43
Ln(Cmax)        99.99  20.3  44   69.96  20.3  44

Fasting Pilot study
                     yours             mine
Dependent      Power   CV(%)  n  “power”  CV%   n
Ln(AUCINF_obs)   0.48  37.07 14    5.49  37.07 15
Ln(AUClast)      0.56  32.34 14   18.35  32.34 15
Ln(Cmax)         0.81  23.13 14   33.73  23.13 15

Fasting Pivotal Study
                     yours             mine
Dependent      Power   CV(%)  n  “power”  CV%   n
Ln(AUCINF_obs) 100.0   18.0  61  100.00  18.0  60
Ln(AUClast)    100.0   18.3  61  100.00  18.3  60
Ln(Cmax)       100.0   21.9  61    2.68  21.9  61

Why are you notoriously not answering questions raised by ElMaestro, John, and myself? If you only here to watch for …

❝ the justification for repeating the study

… be prepared for a rather extended waiting period.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Regulatory Query for study repeat sam 2013-07-27 07:50 
  • Repeats ElMaestro 2013-07-27 11:01
    • Repeats sam 2013-07-27 11:18
      • Repeats ElMaestro 2013-07-27 11:31
        • Repeats sam 2013-07-27 11:57
          • Repeats ElMaestro 2013-07-27 12:27
            • Repeats sam 2013-07-27 12:45
          • Bad science Helmut 2013-07-27 14:15
            • Bad science sam 2013-07-28 09:05
              • Posting style & incomplete information Helmut 2013-07-28 12:32
                • Posting style & incomplete information sam 2013-07-29 06:46
                  • RTFM! Helmut 2013-07-29 07:53
                    • RTFM! sam 2013-07-29 08:40
                      • copy & paste error or what?Helmut 2013-07-29 11:14
                        • copy & paste error or what? sam 2013-07-29 12:46
                    • Calm down! jag009 2013-07-29 16:06
                  • Slightly off-topic: The wonders of pilot trials ElMaestro 2013-07-29 09:19
                    • Futility rule? Helmut 2013-07-29 12:16
                      • Futility rule? ElMaestro 2013-07-29 12:46
                    • Slightly off-topic: The wonders of pilot trials sam 2013-07-29 12:41
                      • PE of AUC? Helmut 2013-07-29 12:45
                        • PE of AUC? sam 2013-07-29 12:56
                          • EOD Helmut 2013-07-29 13:18
                  • Posting style & incomplete information jag009 2013-07-29 16:32
                    • Posting style & incomplete information sam 2013-07-30 06:08
              • Bad science ElMaestro 2013-07-28 12:43
        • Repeats jag009 2013-07-27 22:17
          • Repeats ElMaestro 2013-07-27 23:11
  • Regulatory Query for study repeat jag009 2013-07-27 22:29
    • Regulatory Query for study repeat sam 2013-07-29 12:36
      • Regulatory Query for study repeat luvblooms 2013-07-30 08:28
        • More questions.. jag009 2013-07-30 16:53