Pediatric study for a combination product [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-20 19:59  – Posting: # 21185
Views: 747

(edited by jag009 on 2020-02-20 23:12)

Hi,

Question:
For the development of a fixed dose combination (FDC) product containing two ingredient, is there a need to do pediatric PK study
  1. if the individual references' dosages are applicable to adolescent 12 and up and adult? ie: FDC contains 10 mg A and 20 mg B. A @ 10 mg and B @ 20 mg can be taken by 12 yrs old. And there is no drug drug interaction.
  2. if the new FDC has a new dosing interval that is different from both references?

Thx
J

Complete thread:

Activity
 Admin contact
20,456 posts in 4,296 threads, 1,413 registered users;
online 13 (0 registered, 13 guests [including 11 identified bots]).
Forum time (Europe/Vienna): 19:13 CEST

No one wants to learn from mistakes, but we cannot learn enough
from successes to go beyond the state of the art.    Henry Petroski

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