Denmark Curiosa (1 in 90% CI in 0.8-1.25): Gone [Power / Sample Size]

posted by Helmut Homepage – Vienna, Austria, 2019-11-08 12:47 (1051 d 10:48 ago) – Posting: # 20765
Views: 7,369

Hi zizou, everybody and nobody,

sorry for excavating this one.

» It was mentioned here several times that Danish Medicines Agency has one more requirement for BE:
»

"In the opinion of the Danish Medicines Agency, the 90 % confidence intervals for the ratio of the test and reference products should include 100 %, regardless that the acceptance limits are within 80.00-125.00 % or a narrower interval. Deviations are usually only accepted if it can be adequately proved that the deviation has no clinically relevant impact on the efficacy and safety of the medicinal product." source (bolded by me)


This week in Athens three assessors of the Danish agency attended the training and told that this requirement is not enforced any more. Also removed from the website updated in July 2019.

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