FDA scaling for NTIDs [Design Issues]

posted by krishna – India, 2013-01-18 11:04 (3977 d 18:32 ago) – Posting: # 9889
Views: 6,590

Hi Helmut,

Thanks for your reply.

❝ Hhm, \(\small{\sqrt{0.80\times 0.93}\neq 0.86}\). ;-) If I interpret your example right the study was a full replicate in 32 subjects.

It is 86.25.

❝ 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 ?



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