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RegisterGeneric FDC drug vs two monoproduct drug or vs "originator" FDC drug? [Design Issues]
Hello to everybody!
There is generic FDC drug named AB which is intended to be studied in BE study. There are two options to choose reference drug (s) for that study:
1. two separate monoproducts - named drug A and drug B. Both drugs considered as reference drugs
2. "original" FDC drug named AB which is also considered as reference drug.
Which drug (s) to choose as reference drug (s)? What would be your opinion?
THX in advance.
There is generic FDC drug named AB which is intended to be studied in BE study. There are two options to choose reference drug (s) for that study:
1. two separate monoproducts - named drug A and drug B. Both drugs considered as reference drugs
2. "original" FDC drug named AB which is also considered as reference drug.
Which drug (s) to choose as reference drug (s)? What would be your opinion?
THX in advance.
—
Best regards
Beholder
Best regards
Beholder
Complete thread:
- Generic FDC drug vs two monoproduct drug or vs "originator" FDC drug?Beholder 2018-09-04 11:12 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Generic FDC: EMA-approach Helmut 2018-09-04 13:04
- Generic FDC: EMA-approach Beholder 2018-09-04 13:27
- Generic FDC: EMA-approach Helmut 2018-09-04 13:38
- Generic FDC: EMA-approach Beholder 2018-09-04 15:23
- Generic FDC: EMA-approach Helmut 2018-09-04 13:38
- Generic FDC: EMA-approach Beholder 2018-09-04 13:27
- Generic FDC: EMA-approach Helmut 2018-09-04 13:04
Ing. Helmut Schütz