EMA: What do I need if I want to run an overdose study [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-01-28 20:12 (240 d 22:08 ago) – Posting: # 21092
Views: 2,950

Hi all,

Need some help with running studies in Europe. If I want to run a PK study under each of the two scenarios:
  1. With a drug that is not approved in Europe but approved in USA, and i want to dose at a total daily dose higher than the total daily dose per label in USA.
  2. With a drug that is approved in Europe but at a higher total daily dose than that on the label.
What do I need to file? I know in US I need IND, in Canada I need a full CTA (30 days). what about in Europe? how long?

Thx
J

Complete thread:

Activity
 Admin contact
21,075 posts in 4,394 threads, 1,468 registered users;
online 2 (0 registered, 2 guests [including 1 identified bots]).
Forum time: Friday 19:21 CEST (Europe/Vienna)

If you think it’s simple,
then you have misunderstood the problem.    Bjarne Stroustrup

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