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RegisterCVintra result of outlier [Study Assessment]
Hi jag009,
as far as I understood the subject completed two reference treatments, one with detectable drug concentrations and one without = no profile. You could argue that the reference product is of such a poor quality that inclusion of the period without profile would on the one side affect the comparison with the test product in a negative way and on the other side would give a wrong impression on the intra-individual variability of the reference product. According to EMA guideline:
“The applicant should justify that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers.”
Maybe this helps.
Kind regards
Dan
as far as I understood the subject completed two reference treatments, one with detectable drug concentrations and one without = no profile. You could argue that the reference product is of such a poor quality that inclusion of the period without profile would on the one side affect the comparison with the test product in a negative way and on the other side would give a wrong impression on the intra-individual variability of the reference product. According to EMA guideline:
“The applicant should justify that the calculated intra-subject variability is a reliable estimate and that it is not the result of outliers.”
Maybe this helps.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Question about subject with very few timepoints jag009 2013-04-25 17:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reliable profile Helmut 2013-04-25 18:16
- Reliable profile jag009 2013-04-25 20:19
- Reliable profile ElMaestro 2013-04-25 22:40
- CVintra result of outlierDr_Dan 2013-04-26 08:58
- Reliable profile ElMaestro 2013-04-25 22:40
- Reliable profile jag009 2013-04-25 20:19
- Reliable profile Helmut 2013-04-25 18:16
Ing. Helmut Schütz