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RegisterRoute of administration other than oral for concomitant medication [Bioanalytics]
Dear qualityassurance
In case of a bioequivalence study, it also depends on whether the concomitant medication was
given obligatory to all subjects or was taken accidentally by one or maybe more subjects. In the first case, the effect for the test and the reference formulation would be the same and you do not need to argue. Otherwise, a detailed risk analysis should be carried out, which describes the estimated PK effects of the concomitant medication on the bioequivalence decision. If only a view subjects are affected a sensitivity analysis could be carried out.
I hope this helps.
In case of a bioequivalence study, it also depends on whether the concomitant medication was
given obligatory to all subjects or was taken accidentally by one or maybe more subjects. In the first case, the effect for the test and the reference formulation would be the same and you do not need to argue. Otherwise, a detailed risk analysis should be carried out, which describes the estimated PK effects of the concomitant medication on the bioequivalence decision. If only a view subjects are affected a sensitivity analysis could be carried out.
I hope this helps.
—
Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- Route of administration other than oral for concomitant medication qualityassurance 2020-02-04 11:28
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Route of administration other than oral for concomitant medication jag009 2020-02-04 19:43
- Route of administration other than oral for concomitant medication Ohlbe 2020-02-05 10:13
- Route of administration other than oral for concomitant medicationDr_Dan 2020-02-11 16:20
Ing. Helmut Schütz