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RegisterAmlodipine/Valsartan [Design Issues]
Hello Kumarnaidu2!
I believe that for Amlodipine the ISCV would be LT 30%, so by default the ABE calculation becomes applicable. So what advantages would be there to have such statistical plan?
Further- analysis of Amlodipine would be required to link any AE for last period. And if it is analyzed, what can be the justification for not using in PK stat?
Regards,
Divyen
❝ 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 believe that for Amlodipine the ISCV would be LT 30%, so by default the ABE calculation becomes applicable. So what advantages would be there to have such statistical plan?
Further- analysis of Amlodipine would be required to link any AE for last period. And if it is analyzed, what can be the justification for not using in PK stat?
Regards,
Divyen
Complete thread:
- Amlodipine/Valsartan Bebac user 2023-09-09 06:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
- Amlodipine/Valsartan Kumarnaidu2 2023-12-06 09:36
- Amlodipine/Valsartandshah 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/Valsartandshah 2023-12-06 16:49
- Amlodipine/Valsartan Kumarnaidu2 2023-12-06 09:36
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
Ing. Helmut Schütz