Potency correction - example [Regulatives / Guidelines]

posted by Ohlbe – France, 2018-06-25 12:10 (2188 d 12:36 ago) – Posting: # 18957
Views: 5,603

Dear El Maestro,

❝ I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.

❝ 90% CI is 77-108 [...]



Now let's take the opposite example: 90% CI is 81-110. Contents: 103% for T, 97% for R. Baseline correction and assay results pre-specified in the protocol. Outcome after correction: the study fails.

Regards
Ohlbe

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