Retention Sample for EU [Regulatives / Guidelines]

posted by Ohlbe – France, 2013-08-20 15:54 (4691 d 16:44 ago) – Posting: # 11320
Views: 2,555

Dear Alagu,

First please read the Forum policy, particularly under 'search' and 'be polite'.

❝ Investigational product retension period for Europe submission?


There is no requirement in the EU to keep retention samples at the trial site. This is a US requirement.

Regards
Ohlbe

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
120 visitors (0 registered, 120 guests [including 15 identified bots]).
Forum time: 08:39 CEST (Europe/Vienna)

The great tragedy of Science – the slaying
of a beautiful hypothesis by an ugly fact.    Thomas Henry Huxley

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