EMEA for HVDP [Regulatives / Guidelines]

posted by pravin17 – India, 2010-11-01 10:59 (5705 d 16:18 ago) – Posting: # 6098
Views: 3,060

(edited on 2010-11-01 13:42)

Dear Friends,

As per EMEA guideline Widen range For Cmax BE crieteria, IF %CV is 46 wat shd be range we use to conclude the result.

Clarify the same

Pravin Borde



Edit: Wat shd be range? Please see this post and also that one concerning questions regarding regulatory issues! [Jaime]

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
150 visitors (0 registered, 150 guests [including 16 identified bots]).
Forum time: 04:17 CEST (Europe/Vienna)

Always listen to experts.
They’ll tell you what can’t be done and why.
Then do it.    Robert A. Heinlein

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