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Acceptance ranges [BE/BA News]

posted by Jaime_R – Barcelona, 2010-08-03 19:03 (5809 d 18:02 ago) – Posting: # 5712
Views: 8,787

Dear Helmut and all,

interesting; now we have the first official statement about some NTIDs!

Tacrolimus: 90%-111% for AUC and 80%-125% for C_max
Ciclosporine: 90%-111% for AUC and C_max (fasting and fed)

Also a clear statement, where widening for C_max is not acceptable (Clopidogrel, Losartan).

—
Regards, Jaime

Complete thread:

EMA: Questions & Answers Helmut 2010-08-03 16:38
- Acceptance rangesJaime_R 2010-08-03 17:03

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