powell
☆    

China,
2020-02-10 04:36
(182 d 03:03 ago)

Posting: # 21156
Views: 1,256
 

 clinicaltrials registration [Regulatives / Guidelines]

Hi, shold Bioequivalence studies be registered on clinicaltrials website in EU?
Dr_Dan
★★  

2020-02-11 15:03
(180 d 16:36 ago)

@ powell
Posting: # 21158
Views: 778
 

 clinicaltrials registration

Hi
The European Union Clinical Trials Register is intended for protocols and results information on:
a) interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
b) clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
There is no need to register bioequivalence studies that are conducted outside EU and EEA.
I hope this helps.

Kind regards and have a nice day
Dr_Dan
powell
☆    

China,
2020-02-13 09:00
(178 d 22:40 ago)

@ Dr_Dan
Posting: # 21170
Views: 724
 

 clinicaltrials registration

Thank you Dr Dan!


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Activity
 Admin contact
20,991 posts in 4,375 threads, 1,460 registered users;
online 19 (0 registered, 19 guests [including 12 identified bots]).
Forum time: Monday 07:40 UTC (Europe/Vienna)

[Those] who have an excessive faith in their theories or in their
ideas are not only poorly disposed to make discoveries, but they
also make very poor observations.    Claude Bernard

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