Bioequivalence and Bioavailability Forum • Amlodipine/Valsartan

Amlodipine/Valsartan [Design Issues]

posted by Helmut – Vienna, Austria, 2023-09-12 08:48 (570 d 04:22 ago) – Posting: # 23717
Views: 3,438

Hi Bebac user,

❝ The combination of Amlodipine and valsartan was published as two periods crossover but after checking the variability of Valsartan, it had more than 30%. Therefore, should I in those cases design this study as replicated or un-replicated?

There is no product-specific guidance of the EMA and the FDA recommends 2×2×2 crossovers (fasting and fed). Any replicated design can be assessed for (conventional, unscaled) average bioequivalence. However, if you aim at reference-scaling, I would be wary to base the sample size on the CV_w of a 2×2×2 design because the CV_wR is unknown (see this article).

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Complete thread:

Amlodipine/Valsartan Bebac user 2023-09-09 06:34 [Design Issues]
- Amlodipine/ValsartanHelmut 2023-09-12 06:48
  - Amlodipine/Valsartan Kumarnaidu2 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