Pediatric study for a combination product [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-20 19:59 (949 d 02:12 ago) – Posting: # 21185
Views: 1,657

(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:

UA Flag
Activity
 Admin contact
22,390 posts in 4,685 threads, 1,594 registered users;
online 4 (0 registered, 4 guests [including 3 identified bots]).
Forum time: Monday 23:11 CEST (Europe/Vienna)

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

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