is Perindoprilat optional? [Regulatives / Guidelines]

posted by mittyri – Russia, 2018-05-17 22:47  – Posting: # 18779
Views: 1,327

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?

Kind regards,
Mittyri

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