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RegisterFixed Dose combination (FDC) [Design Issues]
Dear HS
We are planning for a dossier submission of a FDC to europe. It has three strengths - 80+12.5, 160+12.5 & 160+25. In this If I plan a study on 160+25, can I get a waiver for the other two strengths.
All these strengths have qualitatively same composition and dose-weight proportionate, except the 160+12.5, where it is not. Should I do an additional study on this strength?
We are planning for a dossier submission of a FDC to europe. It has three strengths - 80+12.5, 160+12.5 & 160+25. In this If I plan a study on 160+25, can I get a waiver for the other two strengths.
All these strengths have qualitatively same composition and dose-weight proportionate, except the 160+12.5, where it is not. Should I do an additional study on this strength?
Complete thread:
- Fixed Dose combination (FDC)drplacebo 2007-06-27 06:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Fixed Dose combination (FDC) Ohlbe 2007-06-27 22:45
Ing. Helmut Schütz