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RegisterFixed Dose combination (FDC) [Design Issues]
Dear drplacebo,
Proportionality of the formulation is only one of the criteria listed in section 5.4 of the EU Note for Guidance. Please also note that depending on the (non-)linearity of the PK of the two active substances you may have to conduct your trial using the 80 + 12.5 formulation and not on the 160 + 25 formulation (see section 9 of the Q&A document for additional detail).
Unless you meet the "5 % rule" in bullet 4 of section 5.4 of the Note for Guidance, you will have to perform also a trial on the 160 + 12.5 formulation.
Regards
Ohlbe
Proportionality of the formulation is only one of the criteria listed in section 5.4 of the EU Note for Guidance. Please also note that depending on the (non-)linearity of the PK of the two active substances you may have to conduct your trial using the 80 + 12.5 formulation and not on the 160 + 25 formulation (see section 9 of the Q&A document for additional detail).
Unless you meet the "5 % rule" in bullet 4 of section 5.4 of the Note for Guidance, you will have to perform also a trial on the 160 + 12.5 formulation.
Regards
Ohlbe
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