Bioequivalence and Bioavailability Forum

Results Analysis [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2014-07-08 12:08 (4018 d 18:42 ago) – Posting: # 13235
Views: 16,832

Hi unique_one,

Excellent example.

❝ Questions:

❝

❝ 1. Primary reason for BE Failure?

Noone can tell. It might be a bioinequivalent product, or it might be a bioequivalent product. Your result cannot distinguish the two.

❝ 2. Do re-formulation would be needed?

If you think the two products are bioinequivalent, then obviously yes.
If you think the two products are bioequivalent with the estimated GMR reflecting true product performance, then you might not be able to afford the sample size necessary for another study in which case reformulation is necessary.
You might opt for a repeat study, too. You can probably assume any GMR within the CI's (although a GMR close to the some of the extremes are likely a bit unwise and unethical. Hötzi rants are a possibility).

There is little literature covering such situations, but I know people are working on it - publication within 12 months or so...

Complete thread:

• Results Analysis unique_one 2014-07-08 08:58 [Study As­sess­ment] 
  • Results AnalysisElMaestro 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 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