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Registerdifferent requirements for BE studies in US and EU [Design Issues]
Dear Forum,
Would anyone guide me why USFDA asks for most of the BE studies to be conducted under both fasting and fed conditions whereas CPMP/EMEA asks for most of BE studies to be conducted under either fasting or fed conditions?
Regards,
Vinod
Would anyone guide me why USFDA asks for most of the BE studies to be conducted under both fasting and fed conditions whereas CPMP/EMEA asks for most of BE studies to be conducted under either fasting or fed conditions?
Regards,
Vinod
Complete thread:
- different requirements for BE studies in US and EUvinodar 2007-07-12 06:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Specific requirements for food intake (EU) Helmut 2007-07-13 20:26
- Clinical Trial Forum? vinodar 2007-07-15 08:31
- Clinical Trial Forum? Helmut 2007-07-15 14:21
- Clinical Trial Forum? vinodar 2007-07-15 08:31
- Specific requirements for food intake (EU) Helmut 2007-07-13 20:26
Ing. Helmut Schütz