Pediatric study for a combination product [Regulatives / Guidelines]
Hi,
Question:
For the development of a fixed dose combination (FDC) product containing two ingredient, is there a need to do pediatric PK study
Thx
J
Question:
For the development of a fixed dose combination (FDC) product containing two ingredient, is there a need to do pediatric PK study
- 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.
- if the new FDC has a new dosing interval that is different from both references?
Thx
J
Complete thread:
- Pediatric study for a combination productjag009 2020-02-20 19:59 [Regulatives / Guidelines]
- Pediatric study for a combination product Dr_Dan 2020-03-03 15:53