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RegisterFailure of BE in fasting studies [Study Assessment]
❝ Say for example, if the formulation shows highly variable nature under fasting conditions, doing a routine two period, two way, cross over design is not going to help. You need to change your design to a Replicate design so that the formulation passes under fasting condition too.
Dear Dr. Gunasakaran,
Can you elaborate more on the above statement with some illustrations (If possible)?
Is it possible that a formulation will pass in replicate design and same will fail in 2 way crossover?
What impact will be on ratio and 90% CI, If I test same formulation in 2 way crossover and replicate design?
Regards,
drsinghs
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 studies cakhatri 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 studiesdrsinghs 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 studies cakhatri 2012-10-10 07:34
- Failure of BE in fasting studies drgunasakaran1 2012-10-09 20:07
Ing. Helmut Schütz