Bioequivalence and Bioavailability Forum

Oxcarbazepine Tablet Study design [Design Issues]

posted by Helmut  – Vienna, Austria, 2024-08-24 14:19 (23 d 18:18 ago) – Posting: # 24159
Views: 397

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 -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?

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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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