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

posted by jag009  – NJ, 2020-01-28 20:12  – Posting: # 21092
Views: 1,197

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
20,342 posts in 4,271 threads, 1,402 registered users;
online 7 (1 registered, 6 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 19:17 CET

Every man gets a narrower and narrower field of knowledge
in which he must be an expert in order to compete with other people.
The specialist knows more and more about less and less
and finally knows everything about nothing.    Konrad Lorenz

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