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Register4-period BE study fed/fasting: statistical issues [General Statistics]
Dear all,
We are preparing a 4-period single-dose BE study under both fed and fasting conditions (as described in the new draft BE/BA EMEA guidance: Test fast/Ref fast/Test fed/Ref fed).
However, the product we are developing has a great food effect and a high within-subject variability in fed conditions (not under fasting conditions).
Our concern is:
Do you confirm the increase of residual variability in such a study and the difficulties to prove bioequivalence under fasting conditions?
Thank you in advance for your answers.
Best regards.
Amandine
We are preparing a 4-period single-dose BE study under both fed and fasting conditions (as described in the new draft BE/BA EMEA guidance: Test fast/Ref fast/Test fed/Ref fed).
However, the product we are developing has a great food effect and a high within-subject variability in fed conditions (not under fasting conditions).
Our concern is:
- is it possible to compare each product in fed conditions versus fasting conditions (ie, food effect of each formulation) whereas the variances will be greatly different under fed and fasting conditions?
- moreover, we think that the residual variability of the 4-way ANOVA will be penalized (strongly increased) by the fed arms. Consequently, we fear not to prove bioequivalence between Test and Reference, even in fasting conditions, because of this high residual CV.
Do you confirm the increase of residual variability in such a study and the difficulties to prove bioequivalence under fasting conditions?
Thank you in advance for your answers.
Best regards.
Amandine
Complete thread:
- 4-period BE study fed/fasting: statistical issuesAmandine 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