Bioequivalence and Bioavailability Forum • Oxcarbazepine Tablet Study design

Oxcarbazepine Tablet Study design [Design Issues]

posted by AB661 – India, 2024-08-24 13:00 (661 d 00:27 ago) – Posting: # 24158
Views: 4,510

❝ 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.

Dear Sir,

CV for AUC is 15 %.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]

Complete thread:

Oxcarbazepine Tablet Study design AB661 2024-07-13 09:02
- 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 designAB661 2024-08-24 11:00
    - Oxcarbazepine Tablet Study design Helmut 2024-08-24 12:19