Bioequivalence and Bioavailability Forum

TRT / RTR Design [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2017-05-04 00:04 (2932 d 04:19 ago) – Posting: # 17303
Views: 9,910

Hi Hötzi,

❝ ❝ "The approach of reference-scaled average BE (RSABE) requires that the reference formulation be measured twice in each subject."

❝ … slipped through my intention. My fault. This statement is – despite the two great authors – wrong.

Not your fault. As a reviewer you are not and will never be responsible for anything authored by others.

But having said that I think the sentence is OK, only the meaning is a bit out of context. To calculate meaningfully the intra-subject variability for Ref we need subjects in whom it has been measured (at least) twice. That was presumably what the authors tried to remind readers.
The entire issue of rsaBE cannot be approached in the absence of such subjects, and therefore the sentence makes quite some sense.

Blumentopferde

Complete thread:

• TRT / RTR Design Yura 2017-05-01 09:34 
  • TRT / RTR Design mittyri 2017-05-02 18:38
    • TRT / RTR Design Yura 2017-05-02 21:19
      • TRT / RTR Design Helmut 2017-05-02 22:04
        • TRT / RTR Design Yura 2017-05-03 07:41
          • TRT / RTR Design Helmut 2017-05-03 21:49
            • TRT / RTR DesignElMaestro 2017-05-03 22:04
              • TRT / RTR Design Helmut 2017-05-06 18:33
                • TRR / RTT Design Yura 2017-05-09 11:35
                  • TRR / RTT Design Helmut 2017-05-09 13:06
                    • TRR / RTT Design Yura 2017-05-09 16:18
                      • TRR / RTT Design Helmut 2017-05-09 16:56
                        • TRR / RTT Design Yura 2017-05-09 17:36
                          • TRR / RTT Design Helmut 2017-05-09 17:53
                            • TRR / RTT Design Yura 2017-05-09 18:07