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RegisterFailure of BE in fasting studies [Study Assessment]
Dear Mr ABE,
It may be due to the variable absorption of the drug under fasting conditions. Sometimes, food enhances the absorption of the molecule and its pharmacokinetic parameters will show less variations under fed conditions. In these cases, the formulation will pass under fed conditions, but will fail in fasting study.
In these cases, it is better to do a pilot study in Fasting condition first, if the literature shows high variability and lesser absorption under fasting condition. If the formulation passes in Fasting condition, then it has higher chances of passing under Fed condition.
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.
In the above scenario, I will suggest you to go for Replicate design for Fasting study and Two period, Two way, Cross over under Fed conditions.
It may be due to the variable absorption of the drug under fasting conditions. Sometimes, food enhances the absorption of the molecule and its pharmacokinetic parameters will show less variations under fed conditions. In these cases, the formulation will pass under fed conditions, but will fail in fasting study.
In these cases, it is better to do a pilot study in Fasting condition first, if the literature shows high variability and lesser absorption under fasting condition. If the formulation passes in Fasting condition, then it has higher chances of passing under Fed condition.
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.
In the above scenario, I will suggest you to go for Replicate design for Fasting study and Two period, Two way, Cross over under Fed conditions.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
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 studiesdrgunasakaran1 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 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 studies cakhatri 2012-10-10 07:34
- Failure of BE in fasting studiesdrgunasakaran1 2012-10-09 20:07
Ing. Helmut Schütz