FDA, again [R for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2020-01-09 15:04 (467 d 19:45 ago) – Posting: # 21070
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[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 🖖
Helmut Schütz
[image]

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