ask the EMA oracle [Outliers]
❝ A little bit curious for me is the underlined sentence. Taken literally it would not allow to exclude such profiles for the Test formulation .
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.
- Profiles with no measurable concentrations vezz 2011-10-06 12:45