powell
☆    

China,
2020-02-10 06:36
(2326 d 15:12 ago)

Posting: # 21156
Views: 4,143
 

 clinicaltrials registration [Regulatives / Guidelines]

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

Germany,
2020-02-11 17:03
(2325 d 04:45 ago)

@ powell
Posting: # 21158
Views: 3,113
 

 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 11:00
(2323 d 10:49 ago)

@ Dr_Dan
Posting: # 21170
Views: 3,049
 

 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]
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
133 visitors (0 registered, 133 guests [including 26 identified bots]).
Forum time: 22:49 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution.    Theodosius Dobzhansky

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