505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ [Design Issues]

posted by Brus – Spain, 2021-01-25 17:56 (1181 d 21:16 ago) – Posting: # 22188
Views: 1,572

Hi Helmut,

❝ So far so good. Since you are mentioning RLD you are targeting the FDA, right?


I called reference product as RLD, but it is not for FDA, it is for EMA. Sorry for the misunderstanding


❝ Is a single (not daily) 150 mg dose approved?


Yes. According SmPC of reference product, it is possible to administer one single dose of 150 mg.

❝ In Europe that’s the hybrid pathway. Additionally to this study generally clinical studies are required as well.


Why? If efficacy has indeed been demonstrated with 150 mg and SmPC establishes a 150 mg dose regimen. What more can you ask for? To my understanding, you just have to show that your 150 mg provided in your tablet will behave in the same way as the 150 mg of the reference product provided by a 100 mg tablet and a 50 mg tablet. What am I missing?

Best regards,

Complete thread:

UA Flag
Activity
 Admin contact
22,988 posts in 4,825 threads, 1,649 registered users;
31 visitors (0 registered, 31 guests [including 4 identified bots]).
Forum time: 16:13 CEST (Europe/Vienna)

As soon as we abandon our own reason, and are content
to rely upon authority, there is no end to our troubles.    Bertrand Russell

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