Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-05-25 09:15 CEST (UTC+2h)
 
Peregrin
Junior

Russia,
2018-03-02 12:05

Posting: # 18493
Views: 500
 

 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
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
18,290 posts in 3,889 threads, 1,169 registered users;
16 users online (0 registered, 16 guests).

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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