Bioequivalence and Bioavailability Forum

Hey wait a moment.... [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2018-06-27 10:29 (2297 d 12:13 ago) – Posting: # 18972
Views: 13,906

Good morning Hötzi,

❝ Good point – I missed that! In the past I did not adjust because only one will be marketed (i.e., the entire patient’s risk lies with this product). However, some regulatory statisticians (you know, coffee break chats) seem to be more strict because one gets two chances of passing. Too lazy to crawl the supplementary material of your paper about pilot studies: Is such a case covered?

Whose paper? Some crackpot had one published paper and it covered the case of one product being tested in a pilot, then in a pivotal trial, depending on the figures. Rumours have it he is working on another manuscript dealing with scenarios like the one in this thread and that reviewers are way too tough. But then again, you cannot always trust rumours. Only trust google and wikipedia.

---

Hi all,

ok you'll think that I am nuts, but I think I will need to put it into reverse here:

Let us say both R1 and R2 are (truly) not BE. For simplicity think of them as products with the exact same properties even though they formally may be called something different. Since we are happy if we approve one of them, applying alpha=5% could inflate the type I error (approval of a non-BE product) if the true relative performances are around the acceptance borders.

We need that alpha correction. Sorry.

---

Edit: Two posts merged. [Helmut]

Complete thread:

• Decision of confidence interval of three period BE study libaiyi 2018-06-26 12:00 
  • Two tests and one reference Helmut 2018-06-26 13:13
    • Two tests and one reference Brus 2020-08-31 09:58
      • Two tests and one reference ElMaestro 2020-08-31 10:23
      • Two regions: No α adjustment Helmut 2020-08-31 10:26
        • Two regions: No α adjustment Brus 2020-08-31 11:09
          • Two regions: different populations Helmut 2020-08-31 11:26
  • Decision of confidence interval of three period BE study ElMaestro 2018-06-26 22:20
    • Any of two tests and one reference Helmut 2018-06-27 00:33
      • Any of two tests and one reference libaiyi 2018-06-27 08:25
      • Hey wait a moment....ElMaestro 2018-06-27 08:29
        • Hey wait a moment.... Helmut 2018-06-27 11:45
          • Pilot or pivotal ? Ohlbe 2018-06-27 12:14
            • Pilot or pivotal ? ElMaestro 2018-06-27 13:01
              • Pilot or pivotal ? Ohlbe 2018-06-27 14:13
                • Pilot or pivotal ? ElMaestro 2018-06-27 14:48
                  • Pilot or pivotal ? Ohlbe 2018-06-27 15:43
                    • Pilot or pivotal ? ElMaestro 2018-06-27 22:13
            • Pilot or pivotal ? jag009 2018-06-29 20:53
              • Pilot or pivotal ? ElMaestro 2018-06-29 22:11
                • Pilot or pivotal ? jag009 2018-07-03 17:38
          • Hey, hey wait another moment.... d_labes 2018-06-28 19:48
            • Hey, hey wait another moment.... Helmut 2018-07-03 17:22
              • Old belives die hard d_labes 2018-07-04 13:28