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Registeris Perindoprilat optional? [Regulatives / Guidelines]
Dear All,
could you please enlighten me what is the reason to analyse and describe PK of Perindoprilat when one of APIs is Perindopril (as an example)?
As EMA stated
Also for inactive prodrugs, demonstration of bioequivalence for parent compound is recommended.
The active metabolite does not need to be measured.
What is the reason why the experts could insist to include Perindoprilat to the list of analytes?
could you please enlighten me what is the reason to analyse and describe PK of Perindoprilat when one of APIs is Perindopril (as an example)?
As EMA stated
Also for inactive prodrugs, demonstration of bioequivalence for parent compound is recommended.
The active metabolite does not need to be measured.
What is the reason why the experts could insist to include Perindoprilat to the list of analytes?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- is Perindoprilat optional?mittyri 2018-05-17 22:47 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Need to know vs. nice to know Helmut 2018-05-18 12:35
- where nice to know is mandatory mittyri 2018-05-19 23:46
- ...and apart from that Perindopril is not a difficult analyte ElMaestro 2018-05-18 14:26
- ...and apart from that Perindopril is a difficult analyte Ohlbe 2018-05-18 15:26
- Need to know vs. nice to know Helmut 2018-05-18 12:35
Ing. Helmut Schütz