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RegisterBioequivalence of mirabegron 50 mg extended release Tablet [Design Issues]
Dear All
I had performed a 2X2 crossover study between test and reference product of mirabegron 50 mg under fasting conditions where 34 volunteers were completed the study.
Knowing that I couldn't find an accurate data for intrasubject variability of Mirabegnon. The results showed a very high unexpected intra-subject variability as following:
Cmax: 73.8451%, AUCt: 67.6524%
I calculated study power too and it results as following:
Cmax: 38.45% and AUCt: 42.38%
Therefore, a sequential two stage study won't be applicable in that condition. My question is: If i repeat the aforementioned study again, shall i follow a partial replicated cross over design or full replicated cross over design?
My second: Shall i follow RASBE or unscaled BE limits ?
Thanks in advance
I had performed a 2X2 crossover study between test and reference product of mirabegron 50 mg under fasting conditions where 34 volunteers were completed the study.
Knowing that I couldn't find an accurate data for intrasubject variability of Mirabegnon. The results showed a very high unexpected intra-subject variability as following:
Cmax: 73.8451%, AUCt: 67.6524%
I calculated study power too and it results as following:
Cmax: 38.45% and AUCt: 42.38%
Therefore, a sequential two stage study won't be applicable in that condition. My question is: If i repeat the aforementioned study again, shall i follow a partial replicated cross over design or full replicated cross over design?
My second: Shall i follow RASBE or unscaled BE limits ?
Thanks in advance
Complete thread:
- Bioequivalence of mirabegron 50 mg extended release TabletIbrahim Komeil 2021-02-20 11:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Replicate designs based on information of 2×2×2 design Helmut 2021-02-20 14:50
- Replicate designs based on information of 2×2×2 design Ibrahim Komeil 2021-02-20 18:34
- Assumption of authority? Helmut 2021-02-20 20:50
- Replicate designs based on information of 2×2×2 design Ibrahim Komeil 2021-02-20 18:34
- Bioequivalence of mirabegron 50 mg extended release Tablet jishnu 2022-08-04 09:09
- Bioequivalence of mirabegron 50 mg extended release Tablet qualityassurance 2022-08-04 15:47
- Replicate designs based on information of 2×2×2 design Helmut 2021-02-20 14:50
Ing. Helmut Schütz