FDA scaling for NTIDs [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2013-01-20 13:46 (3975 d 16:18 ago) – Posting: # 9893
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Hi Krishna,

❝ ❝ The study passes all criteria. What is the problem?

❝ My problem is, here %(T/R): 86.25, it is far way from the 100 and R-R %CV: 26. Due to higher CV it is passing SABE (it would have been failed in SABE if it had low variability). Then how test can be assured with therapeutic equivalence as Reference with out point estimate constraint ?

We are talking about the FDA. Until recently FDA did not distinguish between NTIDs and other drugs at all. The acceptance range was 80.00–125.00%, no PE restriction. So the study would have passed anyway. If you read the transcripts of the 2010 and 2011 ACPSCP-meetings you will realize the rationale behind the new method is last but not least political (as is the PE restriction for HVDPs). With the aggregate method ≤21.42 %CV the RSABE will mainly be responsible for the decision and >21.42 conventional ABE. This makes sense, since if a NTID is safe and efficacious despite such a variability there is no reason to impose a restriction. Furthermore as Donald Schuirmann showed in his simulations the patient’s risk has a minimum of ~0.025 at 21.42 %CV.

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