FDA, again [🇷 for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2020-01-09 16:04 (865 d 02:27 ago) – Posting: # 21070
Views: 3,739

[image] Dear all,

we know that the FDA uses [image] internally, e.g., in all simulations which lead to its reference-scaling method for NTIDs.

THX to ElMaestro discovering another example. Though I attended the 4th GBHI workshop last month in Bethesda, it is hidden in the backup slides.* Quote:

Q1. What is a sample size to achieve 80% power to pass bioequivalence, assuming CV as 100%, T/R true ratio as 5%?
Q2. With a fixed sample size (n=1,000), what are maximum differences in FEV1 metrics which pass BE with 80% power?

To address questions 1–2;


Of note, Robert Lionberger (Director Office of Research and Standards, Office of Generic Drugs) told me that he visits the forum regularly. :thumb up:



Dif-tor heh smusma 🖖 [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
22,092 posts in 4,630 threads, 1,567 registered users;
online 8 (0 registered, 8 guests [including 6 identified bots]).
Forum time: Monday 19:32 CEST (Europe/Vienna)

There is no adequate defense, except stupidity,
against the impact of a new idea.    Percy Williams Bridgman

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