jag009
★★★

NJ,
2020-02-20 20:59
(1578 d 07:34 ago)

(edited by jag009 on 2020-02-20 23:12)
Posting: # 21185
Views: 2,063
 

 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
  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
Dr_Dan
★★  

Germany,
2020-03-03 16:53
(1566 d 11:40 ago)

@ jag009
Posting: # 21197
Views: 1,239
 

 Pediatric study for a combination product

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
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