Pediatric study for a combination product [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-20 20:59 (1927 d 05:58 ago) – Posting: # 21185
Views: 2,848
(edited 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:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,675 registered users;
50 visitors (0 registered, 50 guests [including 32 identified bots]).
Forum time: 03:58 CEST (Europe/Vienna)

Everything is trivial, if you know the answer.    Thomas Jaki

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