Pediatric study for a combination product [Regulatives / Guidelines]

posted by Dr_Dan  – 2020-03-03 14:53 (318 d 09:09 ago) – Posting: # 21197
Views: 652

Hi John
In principle there is a need for a PIP for all new drug products except generics so also for fixed dose combination (FDC) products, especially if the individual references' dosages are applicable to adolescent and are commonly used together. I am not talking about PK studies but efficacy(!). The fact that the new FDC will have a new dosing interval does not make any difference. Of course you can apply for a PIP-waiver but what would be the arguments? Why should the new product be kept from children? Just saving time and money will not convince PDCO.

Kind regards and have a nice day
Dr_Dan

Complete thread:

Activity
 Admin contact
21,303 posts in 4,441 threads, 1,488 registered users;
online 9 (0 registered, 9 guests [including 3 identified bots]).
Forum time: Saturday 00:02 UTC (Europe/Vienna)

If you can’t solve a problem, then there is an easier problem
you can solve: find it.    George Pólya

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