Bioequivalence and Bioavailability Forum

Don’t hurry; explore consequences [Study As­sess­ment]

posted by Helmut  – Vienna, Austria, 2014-07-08 14:00 (4370 d 11:06 ago) – Posting: # 13237
Views: 20,662

Hi!

❝ However, as you mentioned that by considering the obtained T/R ratio, a higher sample size would be required.

❝ Could you please let me know that what could be in approx sample size if study is repeated?

I strongly suggest not to use values obtained in the study hoping that you get exactly the same ones in a repeated one. They are estimates, not “carved in stone”. Consider reading one of my pre­sen­ta­tions about sample size estimation. You will see that in your case (similar CVs of AUC and C_max) the ratio is more important. To give you a first idea (using exactly the values for AUC): 78 subjects for 80% power and 108 for 90%.
Get / package PowerTOST and run a sensitivity analysis according to ICH E9:

The method by which the sample size is calculated should be given in the protocol, to­geth­er with the estimates of any quantities used in the calculations (such as variances, mean values, […] difference to be detected). The basis of these estimates should also be given. It is impor­tant to investigate the sensitivity of the sample size estimate to a vari­ety of deviations from these assumptions and this may be facilitated by providing a range of sample sizes appro­pri­ate for a reasonable range of deviations from as­sump­tions.

❝ unique_one.

Always remember that you are absolutely unique.
   Just like everyone else.     Margaret Mead

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


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Complete thread:

• Results Analysis unique_one 2014-07-08 08:58 
  • Results Analysis ElMaestro 2014-07-08 10:08
    • Results Analysis unique_one 2014-07-08 10:42
      • Don’t hurry; explore consequencesHelmut 2014-07-08 12:00
        • Don’t hurry; explore consequences unique_one 2014-07-08 14:01
          • The smaller a study, the more un­cer­tain its results Helmut 2014-07-08 17:39
            • The smaller a study, the more un­cer­tain its results unique_one 2014-07-09 06:59
              • The smaller a study, the more un­cer­tain its results unique_one 2014-07-10 07:09
      • 156 ? d_labes 2014-07-08 12:03
        • 156 ? unique_one 2014-07-08 14:03
      • Results Analysis Shuanghe 2014-07-08 12:57
        • Results Analysis unique_one 2014-07-08 14:08
          • Results Analysis Samaya B 2014-07-09 07:58
            • bootstrap Shuanghe 2014-07-09 18:26
              • bootstrap Weidson 2021-07-03 01:36
                • Bootstrapping BE: An attempt in 🇷 Helmut 2021-07-08 13:50
                  • Bootstrapping BE: An attempt in 🇷 ElMaestro 2021-07-09 14:15
                    • Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 14:50
                      • Bootstrapping BE: Desultory thoughts ElMaestro 2021-07-09 16:29
                        • Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 21:04
  • Results Analysis Achievwin 2021-08-17 19:26