No reference-scaling in FARTSSIE [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2022-01-21 22:14 (316 d 08:33 ago) – Posting: # 22737
Views: 720

Hi Bebac user,

❝ Could anyone explain how to conduct a sample size for replicated and partially replicated studies by fartssie tool ?


For (conventional, unscaled) ABE use the Bioequivalence, Replicate-sheet in FARTSSIE. You will note that the sample size of a 4-period full replicate is ≈½ of the 2×2×2 design. The one of a 3-period full replicate and a partial replicate are ≈¾ of the 2×2×2.
If you talk about reference-scaling (the FDA’s RSABE and the EMA’s ABEL), that’s not possible in FARTSSIE (see this thread). There is no analytical solution for power and therefore, the sample size. You need simulations (at least 100,000 for a stable result; see there). I suggest the [image]-package PowerTOST.

Further information:

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
22,427 posts in 4,694 threads, 1,598 registered users;
14 visitors (0 registered, 14 guests [including 9 identified bots]).
Forum time: 06:48 CET (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

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