Bioequivalence and Bioavailability Forum • Amlodipine/Valsartan

Amlodipine/Valsartan [Design Issues]

posted by Kumarnaidu2 – India, 2023-12-07 03:42 (930 d 23:43 ago) – Posting: # 23786
Views: 5,775

Hello dshah

❝ 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?

The reported ISCV for Amlodipine is around 9 to 12%.

Complete thread:

Amlodipine/Valsartan Bebac user 2023-09-09 06:34
- Amlodipine/Valsartan Helmut 2023-09-12 06:48
  - Amlodipine/Valsartan Kumarnaidu2 2023-12-06 09:36
    - Amlodipine/Valsartan dshah 2023-12-06 16:49
      - Amlodipine/ValsartanKumarnaidu2 2023-12-07 02:42
    - Use all data and avoid the partial replicate design for the FDA Helmut 2023-12-07 09:01