Bioequivalence and Bioavailability Forum

Main page Policy Latest Posts Abbreviations

Acceptance ranges [BE/BA News]

posted by Jaime_R – Barcelona, 2010-08-03 19:03 (5802 d 00:23 ago) – Posting: # 5712
Views: 8,765

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

Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
142 visitors (0 registered, 142 guests [including 34 identified bots]).
Forum time: 19:27 CEST (Europe/Vienna)

Scientists cannot simply hang their subjectivities
up on a hook outside the laboratory door. Ruth Bleier

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz