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RegisterConfidence interval [General Statistics]
❝ Fasting study:
❝ 90% CI of AUC0-t, AUC0-inf and Cmax are
❝ 99.88 to 117.06, 98.50 to 113.52 and 96.51 to 121.54 respectively.
❝ GMRatio: AUC0-t, AUC0-inf and Cmax are
❝ 108.13, 105.74 and 108.31 respectively.
❝ Fed study:
❝ 90% CI of AUC0-t, AUC0-inf and Cmax are
❝ 98.92 to 141.62, 105.20 to 140.79 and 98.34 to 154.01 respectively.
❝ GMRatio: AUC0-t, AUC0-inf and Cmax are
❝ 118.36, 121.70 and 123.06 respectively.
It appears that the rate and extent of release of your test formulation is highly significant when compared with reference formulation under fed conditions.
❝ here the CVintra of fasting and fed conditions are 24.65 and
❝ 50.04 respectively for Cmax.
Probably the high intra CV in fed state could be due to lack of enough sample size.
❝ But according to the label the innovator had done the study in fasting
❝ conditions only. But according to the statement of the innovator that the
❝ Cmax of the drug will increase in fed condition is it implies that the
❝ sample size is small when compared to fasting condition. but we had take
❝ same sample size for both the studies (28).
What is the rationale behind selecting the same sample size for both fasting and fed studies? As label suggests there will be increase in rate and extent of release of formulation you could have opted more sample size under fed conditions.
Complete thread:
- Confidence interval MGR 2007-12-13 07:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Confidence interval Helmut 2007-12-13 15:54
- Confidence interval MGR 2007-12-21 05:54
- Confidence intervalvydanark 2007-12-26 11:24
- Confidence interval MGR 2008-01-05 12:23
- Confidence intervalvydanark 2007-12-26 11:24
- Confidence interval MGR 2007-12-21 05:54
- Confidence interval Helmut 2007-12-13 15:54
Ing. Helmut Schütz