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

posted by jag009  – NJ, 2020-02-03 20:23 (543 d 07:13 ago) – Posting: # 21133
Views: 2,893

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.

Agree.

» 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.

Thx
J

Complete thread:

Activity
 Admin contact
21,594 posts in 4,515 threads, 1,532 registered users;
online 19 (0 registered, 19 guests [including 5 identified bots]).
Forum time: Saturday 04:37 CEST (Europe/Vienna)

Restlessness is discontent –
and discontent is the first necessity of progress.
Show me a thoroughly satisfied man 
and I will show you a failure.    Thomas Alva Edison

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