Dr_Dan
★★  

Germany,
2015-11-03 10:27
(3069 d 01:43 ago)

Posting: # 15609
Views: 3,991
 

 New FDC - BE reference products [Regulatives / Guidelines]

Dear all
If you develop a new fixed dose combination with known APIs and you have shown BE of the combination against the US mono reference products do you need to repeat the study with European reference products in case you aim not for substitution indication (according to §10(b)) but go for a mixed application according to §8.3? What is your experience?
Looking forward to your replies.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
nobody
nothing

2015-11-05 16:32
(3066 d 19:39 ago)

@ Dr_Dan
Posting: # 15614
Views: 3,014
 

 New FDC - BE reference products

Hi Dan,

will be hard to convince EU regulators that the product in the EU is identical to the US product, huh?

Maybe start a Sci Adv to get a clue, but don't expect too much, I guess...

Kindest regards, nobody
Dr_Dan
★★  

Germany,
2015-11-09 09:48
(3063 d 02:23 ago)

@ nobody
Posting: # 15627
Views: 2,810
 

 New FDC - BE reference products

Dear nobody
As I explained, it is a new fixed dose combination with known APIs, there is no reference product in the strict sense, only mono product references but if you do not aim for substitution indication (according to §10(b)) but go for a mixed application according to §8.3 do you need to demonstrate BE against the European mono products?
Looking forward to your reply.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
nobody
nothing

2015-11-10 15:01
(3061 d 21:09 ago)

@ Dr_Dan
Posting: # 15628
Views: 2,701
 

 New FDC - BE reference products

Hi Dan, as far as I was concerned: Yes, you have to show anything against a product with a European marketing authorization. No way around that, in my opinion. But as I said: Sci Adv. will help a lot ;-)

Kindest regards, nobody
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
106 visitors (0 registered, 106 guests [including 5 identified bots]).
Forum time: 12:11 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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