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RegisterFailure of BE in fasting studies [Study Assessment]
Dear Dr.Gunasakaran,
Can you confirm if the regulatory will accept two different designs for fast and fed study, to the best of my understanding both the studies have to be of the same design. In case of replicate design, the criteria for establishing BE will differ based on the ISCV obtained from reference.
Regards
Chirag
Can you confirm if the regulatory will accept two different designs for fast and fed study, to the best of my understanding both the studies have to be of the same design. In case of replicate design, the criteria for establishing BE will differ based on the ISCV obtained from reference.
Regards
Chirag
Complete thread:
- Failure of BE in fasting studies ABE1580 2012-10-09 15:42
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
- Failure of BE in fasting studiescakhatri 2012-10-10 07:34
- Failure of BE in fasting studies Dr_Dan 2012-10-10 13:09
- Different designs: why not? Helmut 2012-10-10 13:48
- Different designs: why not? cakhatri 2012-10-12 10:42
- Failure of BE in fasting studies drgunasakaran1 2012-10-10 19:14
- Failure of BE in fasting studies ABE1580 2012-10-11 06:10
- Failure of BE in fasting studies drsinghs 2012-10-11 09:28
- Failure of BE in fasting studies Dr_Dan 2012-10-11 11:43
- 1–β not necessarily = Δ Helmut 2012-10-11 13:05
- Sample size d_labes 2012-10-11 13:10
- +partial replicate Helmut 2012-10-11 17:53
- Failure of BE in fasting studies Dr_Dan 2012-10-11 11:43
- Failure of BE in fasting studiescakhatri 2012-10-10 07:34
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
Ing. Helmut Schütz