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RegisterTRR / RTT Design [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2017-05-09 15:06 (2537 d 12:55 ago) – Posting: # 17333
Views: 8,552
Hi Yura,
Fulfills all requirements for ABEL: CVwR >30%, CI within expanded limits, and PE within 0.8000–1.2500.
Following the ‘logic’ of the EMA’s Q&A document at least 12 subjects should have finished the sequence TRR in order to get a ‘reliable’ estimate of CVwR. I guess that the sample size was 34, right?
If an assessor does not accept this design (not mentioned in the Q&A…) the study demonstrated even ABE.
Yes. By definition BE is the (desired) outcome of a comparison of T with R.
The results of T vs. T are interesting but not relevant. BTW, how did you calculate the GMR and the CI? IMHO, if you use only the data of the sequence RTT (as for CVwT) you can evaluate it only as a paired design (e.g., arbitrarily comparing data of the second administration to the first). Such an evaluation assumes no period effects – which might be false.
❝ What if the design of the TRR / RTT obtained by Cmax
❝ CI T-R = 0.88-1.21;
❝ CV T-R =48%;
❝ expansion [0.71-1.40] CV R-R=47%;
Fulfills all requirements for ABEL: CVwR >30%, CI within expanded limits, and PE within 0.8000–1.2500.
Following the ‘logic’ of the EMA’s Q&A document at least 12 subjects should have finished the sequence TRR in order to get a ‘reliable’ estimate of CVwR. I guess that the sample size was 34, right?
If an assessor does not accept this design (not mentioned in the Q&A…) the study demonstrated even ABE.
❝ GMR T-T=0.708 not belong [0.80; 1.25];
❝ CI T-T = 0.47-1.06;
❝ CV T-T =77%.
❝ Is it possible to draw a conclusion about bioequivalence?
Yes. By definition BE is the (desired) outcome of a comparison of T with R.
The results of T vs. T are interesting but not relevant. BTW, how did you calculate the GMR and the CI? IMHO, if you use only the data of the sequence RTT (as for CVwT) you can evaluate it only as a paired design (e.g., arbitrarily comparing data of the second administration to the first). Such an evaluation assumes no period effects – which might be false.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- TRT / RTR Design Yura 2017-05-01 09:34 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 Design ElMaestro 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 DesignHelmut 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
- TRR / RTT Design Helmut 2017-05-09 17:53
- TRR / RTT Design Yura 2017-05-09 17:36
- TRR / RTT Design Helmut 2017-05-09 16:56
- TRR / RTT Design Yura 2017-05-09 16:18
- TRR / RTT DesignHelmut 2017-05-09 13:06
- TRR / RTT Design Yura 2017-05-09 11:35
- TRT / RTR Design Helmut 2017-05-06 18:33
- TRT / RTR Design ElMaestro 2017-05-03 22:04
- TRT / RTR Design Helmut 2017-05-03 21:49
- TRT / RTR Design Yura 2017-05-03 07:41
- TRT / RTR Design Helmut 2017-05-02 22:04
- TRT / RTR Design Yura 2017-05-02 21:19
- TRT / RTR Design mittyri 2017-05-02 18:38
Ing. Helmut Schütz