ask the EMA oracle [Outliers]

posted by Ohlbe – France, 2011-10-06 18:31 (4372 d 22:55 ago) – Posting: # 7436
Views: 7,597

Dear D. Labes,

❝ A little bit curious for me is the underlined sentence. Taken literally it would not allow to exclude such profiles for the Test formulation :confused:.

My understanding is that this is precisely the idea ! Basically, if no concentration is measured after the reference product, EU regulators are ready to assume that the subject did not swallow the product. The reference formulation is considered to be reliable :-|
If the same situation happens after the test product, they consider that they cannot make the difference between a non-compliant subject and a deficient tablet. They will not take any chance.



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