Pediatric study for a combination product [Regulatives / Guidelines]

posted by jag009  – NJ, 2020-02-20 19:59 (423 d 00:46 ago) – Posting: # 21185
Views: 1,426

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


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?


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