Amlodipine/Valsartan [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2023-09-12 08:48 (312 d 07:10 ago) – Posting: # 23717
Views: 2,121

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 CVw of a 2×2×2 design because the CVwR is unknown (see this article).

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,112 posts in 4,858 threads, 1,644 registered users;
88 visitors (0 registered, 88 guests [including 14 identified bots]).
Forum time: 15:58 CEST (Europe/Vienna)

Statistics means you never have to say you’re certain.    David L. Streiner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5