is Perindoprilat optional? [Regulatives / Guidelines]

posted by mittyri – Russia, 2018-05-17 22:47 (1469 d 20:49 ago) – Posting: # 18779
Views: 2,977

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

Complete thread:

UA Flag
Activity
 Admin contact
22,105 posts in 4,630 threads, 1,566 registered users;
online 11 (1 registered, 10 guests [including 6 identified bots]).
Forum time: Thursday 19:36 CEST (Europe/Vienna)

Operational hectic replaces
intellectual calms.    Alexander Huiskes

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5