Bioequivalence and Bioavailability Forum

Pilot or pivotal ? [General Sta­tis­tics]

posted by jag009  – NJ, 2018-06-29 22:53 (2121 d 08:30 ago) – Posting: # 19000
Views: 12,489

Hi Olhbe

❝ Isn't the common practice to first test T1 and T2 vs. R in a pilot study (and I will not get into a debate on whether alpha correction would be needed), select one of the two test formulations, and then test it in a pivotal study in the usual way ? How often do you see both test formulations directly tested in a pivotal study ?

❝

❝ OK, maybe if the product has a very low variability and the number of subjects remains very low, it could make sense and save time to directly go for the pivotal. Any experience ?

Damn. We did pivotals 4-way crossover 3T vs R before! R&D said no time and material was cheap! I said "Ooooookay..."
John

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