Bioequivalence and Bioavailability Forum

3 period full replicate [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2015-06-24 16:38 (3491 d 09:36 ago) – Posting: # 14977
Views: 31,169

Dear Dr_Dan!

❝ From a leading European regulatory authority I just recieved the information that a 3-period full replicate design (two sequences: T-R-T and R-T-R) for a bioequivalence study will not be accepted. The reason is that for a full replicate design R as well as T need to be repclicated and this is only possible with the respective sequences (so TTRR etc.) ...

Seems the story "Potvin C is not valid in Europe" is duplicated here on another field!

The full replicate 3-period design has the sequences TRT / RTR as is stated in your post and of course has T and R replicated. Not in each subject, but if balanced in half of ntotal each. And this design of course allows the evaluation of the intra-subject variabilities of T and R separately.

So what's the problem of the "leading European regulatory authority"?
Especially in the light of ElMaestro's remark that only the intra-subject variability of R is of any regulatory concern if scaled ABE is aimed for .

Complete thread:

• 3 period full repli­cate Dr_Dan 2015-06-24 13:55 [RSABE / ABEL] 
  • 3 period full replicate ElMaestro 2015-06-24 14:11
  • 3 period full replicate Helmut 2015-06-24 14:29
  • 3 period full replicated_labes 2015-06-24 14:38
    • 3 period full replicate Dr_Dan 2015-06-24 16:43
      • 3 period full replicate Helmut 2015-06-24 18:00
        • 3 period full replicate ElMaestro 2015-06-24 18:11
          • 3 period full replicate Helmut 2015-06-24 18:25
            • 3 period full replicate d_labes 2015-06-25 08:52
              • 3 period full replicate ElMaestro 2015-06-25 10:37
                • OT d_labes 2015-06-25 11:20
                  • OT ElMaestro 2015-06-25 11:54
                    • OT d_labes 2015-06-25 13:51
      • CVs (borderline OT) Helmut 2015-06-26 13:51
        • CVs (R, T) from pooled CV d_labes 2015-07-02 09:09
          • Answering an un­asked ques­tion Helmut 2015-07-02 13:03
            • Answer to an un­asked answer d_labes 2015-07-02 14:21
              • Bloody typo! Helmut 2015-07-02 14:33
        • CVs (borderline OT) zizou 2015-07-05 19:20
          • Degrees of freedom 3-period full replicate d_labes 2015-07-06 11:10
            • Degrees of freedom 3-period full replicate ElMaestro 2015-07-06 11:59
              • Degrees of freedom 3-period full replicate d_labes 2015-07-06 13:53
            • Degrees of freedom 3-period full replicate zizou 2015-07-06 17:25
  • The almighty oracle has spoken! Helmut 2015-07-23 23:54
    • Almighty oracle's mysterious saying d_labes 2015-07-24 08:23