Bioequivalence and Bioavailability Forum 11:42 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Peregrin
Junior

Russia,
2018-03-02 12:05

Posting: # 18493
Views: 741
 

 Generic radiopharmaceuticals [Regulatives / Guidelines]

Dear all,

Does anybody know whether additional non-clinical/clinical or BE requirements (e.g. in terms of radiation comparability) are applied to generic radiopharmaceuticals?

Articles 6 and 9 of Directive 2001/83/EC and Part III.2 of Annex I to the same Directive do not specify any additional requirements to generic radiopharmaceuticals (apart quality aspects of radionuclide generators).

These products are usually presented as true solutions.


All the best
Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
19,190 posts in 4,085 threads, 1,308 registered users;
online 29 (0 registered, 29 guests [including 13 identified bots]).

The aim of science is not to open the door to infinite wisdom,
but to set a limit to infinite error.    Bertolt Brecht

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed