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RegisterIbuprofen racemate or enantiomers [Design Issues]
Dear all,
have you any recent experience with bioequivalence study with ibuprofen (administration of a racemate)? According to the recent EMA Bioequivalence guideline it seems me that enantiomers of this drug should be measured, because all three prerequisites for such design are met. However, I have seen many recent studies where only an achiral method was used. Also the FDA recommends to measure "ibuprofen in plasma", i.e. racemate.
With best regards,
Jan
have you any recent experience with bioequivalence study with ibuprofen (administration of a racemate)? According to the recent EMA Bioequivalence guideline it seems me that enantiomers of this drug should be measured, because all three prerequisites for such design are met. However, I have seen many recent studies where only an achiral method was used. Also the FDA recommends to measure "ibuprofen in plasma", i.e. racemate.
With best regards,
Jan
Complete thread:
- Ibuprofen racemate or enantiomersjanmacek 2011-08-02 15:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ibuprofen enantiomers‽ Helmut 2011-08-03 15:16
Ing. Helmut Schütz