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Registerstatistical evaluations [Regulatives / Guidelines]
Dear Rajasekhar,
If this happens in the period where the subject received the test product, you're in trouble...
To quote the EMA guideline, section 4.1.8:
Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
The exceptions to this are:
1) A subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial.
❝ My doubt is suppose participant completed entire period and he having the plasma samples for all time points but during bio analysis we got only 3 measurable concentrations. In this case is we can consider this data for PK and statistical evaluations.
If this happens in the period where the subject received the test product, you're in trouble...
To quote the EMA guideline, section 4.1.8:
Exclusion of data cannot be accepted on the basis of statistical analysis or for pharmacokinetic reasons alone, because it is impossible to distinguish the formulation effects from other effects influencing the pharmacokinetics.
The exceptions to this are:
1) A subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- statistical evaluations rajasekhar 2017-02-18 11:36 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- statistical evaluations ElMaestro 2017-02-18 12:44
- statistical evaluationsOhlbe 2017-02-20 11:59
- statistical evaluations nobody 2017-02-20 14:35
Ing. Helmut Schütz