Bioequivalence and Bioavailability Forum

Bootstrapping BE: Desultory thoughts [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2021-07-09 18:29 (1018 d 22:20 ago) – Posting: # 22466
Views: 3,311

Hi Hötzi,

❝ Oh dear! Any details?

Read here.

"The Applicant should demonstrate that the consumer risk is not inflated above 5% with the proposed design and alpha expenditure rule, taking into account that simulations are not considered sufficiently robust and analytical solutions are preferred."

❝ Yep. Another issue are ‘outliers’ like in my example. Does it make sense to assume to face them in the pivotal as well? I hope not. Then what? Drop them from the pilot data and bootstrap that?

If you believe an observation is an outlier, for one reason or another, probably it does not make sense to include that observation in the planning. Ot at last this sounds like a healthy argument. On the other hand if you do take the outliers into consideration for the subsequent steps then often the sample size just gets larger.
At any rate, that aberrant value -whether you call it an outlier or not- is more or less what causes the residual to have a bonkers distribution. There may be several of them in the worst case. And then of course there's the issue with a positive and negative residual of equal magnitude subject-wise for a 222BE design. This is more of a triviality-by-design. When it rains it pours.

Complete thread:

• Results Analysis unique_one 2014-07-08 08:58 [Study As­sess­ment] 
  • Results Analysis ElMaestro 2014-07-08 10:08
    • Results Analysis unique_one 2014-07-08 10:42
      • Don’t hurry; explore consequences Helmut 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 thoughtsElMaestro 2021-07-09 16:29
                        • Bootstrapping BE: Desultory thoughts Helmut 2021-07-09 21:04
  • Results Analysis Achievwin 2021-08-17 19:26