Bioequivalence and Bioavailability Forum • Oxcarbazepine Tablet Study design

Oxcarbazepine Tablet Study design [Design Issues]

posted by Helmut – Vienna, Austria, 2024-08-24 14:19 (260 d 15:04 ago) – Posting: # 24159
Views: 1,613

Hi AB661,

❝ ❝ What is your CV for AUC? Like Helmut wrote, Canada requires T/R ratio for Cmax, not 90% CI. Therefore you just need to design and power your study based on CV for AUC.

❝

❝ CV for AUC is 15 %.

Why didn’t you use the [image]

-script suggested above yourself? It gives (for a target power of at least 90%):

design metric method CV T/R n power 2x2x4 Cmax PE 0.43 0.90 22 0.90999 2x2x4 AUC ABE(L) 0.11 0.95 12 0.99972 Sample size is driven by Cmax. With a sample size of 22 power for AUC = 1.00000.

Since the CVs of C_max and AUC are extremely different, this is one of the – rare – cases where the sample size depends on the variability of C_max. You will achieve a very high power for AUC.

P.S: Why have you been waiting for six weeks to provide complete information?

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Complete thread:

Oxcarbazepine Tablet Study design AB661 2024-07-13 09:02 [Design Issues]
- ABE or ABEL for Health Canada Helmut 2024-07-14 12:17
- Oxcarbazepine Tablet Study design jag009 2024-07-23 19:50
  - Health Canada ABEL Helmut 2024-07-24 09:06
  - Oxcarbazepine Tablet Study design AB661 2024-08-24 11:00
    - Oxcarbazepine Tablet Study designHelmut 2024-08-24 12:19