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

posted by jag009  – NJ, 2020-02-03 20:23 (964 d 03:20 ago) – Posting: # 21133
Views: 3,609

Thanks Ohlbe!

» When I read your post I interpreted it differently than Helmut and ElMaestro. So could you clarify your question: would you run those studies to register your drug in Europe, or to register it in the USA ? Helmut and ElMaestro answered with EU registration in mind, I understood you were asking about the authorisation of the studies.

Purely a exploratory study for the interest of science. No registration no drug submission. The drug is marketed in US (IR + ER), IR is available all over the world.

» Being based in the USA, you would need a legal representative in the EU.


» You will need to justify in your protocol (subject safety) and plan the monitoring of the subjects accordingly.

Yes the protocol will implement a lot of medical monitoring, blood chemistry testing, etc. Subjects will be housed in clinic for the entire study.


Complete thread:

UA Flag
 Admin contact
22,385 posts in 4,684 threads, 1,594 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time: Sunday 00:44 CEST (Europe/Vienna)

You really don’t know what you don’t know until you write about it.
Then, everyone knows what you don’t know.    Rod Machado

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