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RegisterBA/BE Studies for Early Termination [Two-Stage / GS Designs]
Dear all,
We are planning to conduct one "Replicate 4-period" bio-equivalence study with 70 subjects.
After completion of clinical phase we will analyze only 40 subjects.
If 40 subject’s data is shown bio-equivalent then we will stop the analysis of remaining 30 subjects. If the data is predictable then we will analyze remaining 30 subjects.
Please clarify whether this approach/design is acceptable to regulatory are not.
Regards
Kotu
Edit: Category changed. [Helmut]
We are planning to conduct one "Replicate 4-period" bio-equivalence study with 70 subjects.
After completion of clinical phase we will analyze only 40 subjects.
If 40 subject’s data is shown bio-equivalent then we will stop the analysis of remaining 30 subjects. If the data is predictable then we will analyze remaining 30 subjects.
Please clarify whether this approach/design is acceptable to regulatory are not.
Regards
Kotu
Edit: Category changed. [Helmut]
Complete thread:
- BA/BE Studies for Early Terminationbalakotu 2015-09-22 13:05
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BA/BE Studies for Early Termination ElMaestro 2015-09-22 13:35
- Dose subjects but not using them d_labes 2015-09-22 13:49
- IMHO, that’s a TSD… Helmut 2015-09-22 13:58
Ing. Helmut Schütz