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Dear Helmut
You are a statistician, I am a project manager. The purpose of a bioequivalence study is not to describe the full pharmacokinetics (including food effect) of a drug entity but to detect differences between galenic formulations. Since it is acceptable to conduct either two separate two-way cross over-studies or a four-way cross-over study in cases where information is required in both the fed and fasted states I would always suggest to perform two separate two-way cross over-studies. I totally agree that from a scientific point of view the four-way cross-over study is much more interesting but from a practical (generic company's) point of view you should prefer the other option.
Kind regards
Dan
You are a statistician, I am a project manager. The purpose of a bioequivalence study is not to describe the full pharmacokinetics (including food effect) of a drug entity but to detect differences between galenic formulations. Since it is acceptable to conduct either two separate two-way cross over-studies or a four-way cross-over study in cases where information is required in both the fed and fasted states I would always suggest to perform two separate two-way cross over-studies. I totally agree that from a scientific point of view the four-way cross-over study is much more interesting but from a practical (generic company's) point of view you should prefer the other option.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- 4-period BE study fed/fasting: statistical issues Amandine 2009-06-04 12:31 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Confounded effects; common variance Helmut 2009-06-04 12:55
- Neglecting period effects? d_labes 2009-06-10 10:10
- Assumptions... Helmut 2009-06-23 14:38
- What if... Ohlbe 2010-03-10 14:27
- What if... Dr_Dan 2010-03-11 15:50
- What if… Helmut 2010-03-11 16:39
- What if…Dr_Dan 2010-03-12 08:49
- Need-to-know / nice-to-know Helmut 2010-03-12 11:35
- many ANOVA but only one trial boonchai_l 2010-05-24 11:53
- many ANOVA but only one trial GSTATS 2010-06-08 21:52
- many ANOVA but only one trial boonchai_l 2010-05-24 11:53
- Need-to-know / nice-to-know Helmut 2010-03-12 11:35
- What if…Dr_Dan 2010-03-12 08:49
- What if… Helmut 2010-03-11 16:39
- What if... Dr_Dan 2010-03-11 15:50
- Neglecting period effects? d_labes 2009-06-10 10:10
- Confounded effects; common variance Helmut 2009-06-04 12:55
Ing. Helmut Schütz