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RegisterAmlodipine/Valsartan [Design Issues]
Dear All,
For the product like Valsartan + Amlodipine or Telmisartan + Amlodipine, is it possible to plan a analysis with 3 way design for Valsartan/Telmisartan and 2 way design for Amlodipine in same study.
For e.g. if we plan a 3 way Partial replicate in 48 subjects (RTR/TRR/RRT). For Val/Telm, sample size will be 48 (All three period) and for Amlodipine, sample size will be 32 (First two period and with sequence RTR and TRR only). Is there any statistical issues with such design?
I know the ideal way is to analyse both Val and Aml in same way.
For the product like Valsartan + Amlodipine or Telmisartan + Amlodipine, is it possible to plan a analysis with 3 way design for Valsartan/Telmisartan and 2 way design for Amlodipine in same study.
For e.g. if we plan a 3 way Partial replicate in 48 subjects (RTR/TRR/RRT). For Val/Telm, sample size will be 48 (All three period) and for Amlodipine, sample size will be 32 (First two period and with sequence RTR and TRR only). Is there any statistical issues with such design?
I know the ideal way is to analyse both Val and Aml in same way.
Complete thread:
- Amlodipine/Valsartan Bebac user 2023-09-09 06:34 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
- Amlodipine/ValsartanKumarnaidu2 2023-12-06 09:36
- Amlodipine/Valsartan dshah 2023-12-06 16:49
- Amlodipine/Valsartan Kumarnaidu2 2023-12-07 02:42
- Use all data and avoid the partial replicate design for the FDA Helmut 2023-12-07 09:01
- Amlodipine/Valsartan dshah 2023-12-06 16:49
- Amlodipine/ValsartanKumarnaidu2 2023-12-06 09:36
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
Ing. Helmut Schütz