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Dear D. Labes,
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.
Regards
Ohlbe
❝ 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.
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Profiles with no measurable concentrations vezz 2011-10-06 12:45 [Outliers]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Profiles with no measurable concentrations Dr_Dan 2011-10-06 14:22
- Profiles with no measurable concentrations ElMaestro 2011-10-06 17:45
- ask the EMA oracle d_labes 2011-10-06 15:24
- ask the EMA oracleOhlbe 2011-10-06 16:31
- Profiles with no measurable concentrations Helmut 2011-10-06 19:14
- Profiles with no measurable concentrations Dr_Dan 2011-10-06 14:22
Ing. Helmut Schütz