where nice to know is mandatory [Regulatives / Guidelines]

posted by mittyri – Russia, 2018-05-19 23:46 (1247 d 03:33 ago) – Posting: # 18790
Views: 2,337

Hi Helmut,

thank you for detailed answer (as always!)

» » What is the reason why the experts could insist to include Perindoprilat to the list of analytes?
»
» I don’t think that they insisted. Was the company’s decision (maybe if the study failed the parent to have sumfink to start an argument). Nowadays in the EEA the metabolite is only nice to know and definitely not mandatory.

Well, I got some discussion with colleagues a while ago. They are confused by the fact that Russian experts insisted on Perindoprilat as mandatory additional analyte.
After referencing to the actual Russian/EEU guidelines (see above) they mentioned that 'there's an actual (common) practice to analyse and to present Perindoprilat within Perindopril in Russia and other counties'
So I was wondering what kind of countries they were mentioning?
OK, FDA/USA.
Then why the hell the guideline is written using EMA approach??
Have you seen so far that experts could insist on metabolites?

Kind regards,
Mittyri

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