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

posted by jag009  – NJ, 2020-01-28 19:12 (405 d 12:21 ago) – Posting: # 21092
Views: 3,434

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
21,372 posts in 4,463 threads, 1,496 registered users;
online 16 (0 registered, 16 guests [including 6 identified bots]).
Forum time: Tuesday 07:33 UTC (Europe/Vienna)

We learn more by looking for the answer to a question and not finding it
than we do from learning the answer itself.    Lloyd Alexander

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