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RegisterStatistical Issue (significant Formulation, Period and seq.) [Regulatives / Guidelines]
Dear sir/Madam
In Bioequivalence study, if formulation (Treatment) effect is significant (since ANOVA p-value is less than 0.05) for both Cmax and AUC and individually for Cmax or AUC, what we can conclude from this significant formulation effect. Similarly, what we can conclude from period and sequence significant effect.
In case of significant formulation effect is that mean number of subject used in the study were more than required.
Regards,
Imran
P.S.
In a statistical analysis of BA/BE data, many time we come across sequence, formulation and period effect in ANOVA (p <0.05). what conclusion should one draw from such data? what would be reason for such effects?
Edit: P.S. attached from new post by Imran of 2007-05-07 15:00 [HS]
In Bioequivalence study, if formulation (Treatment) effect is significant (since ANOVA p-value is less than 0.05) for both Cmax and AUC and individually for Cmax or AUC, what we can conclude from this significant formulation effect. Similarly, what we can conclude from period and sequence significant effect.
In case of significant formulation effect is that mean number of subject used in the study were more than required.
Regards,
Imran
P.S.
In a statistical analysis of BA/BE data, many time we come across sequence, formulation and period effect in ANOVA (p <0.05). what conclusion should one draw from such data? what would be reason for such effects?
Edit: P.S. attached from new post by Imran of 2007-05-07 15:00 [HS]
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Dr.Imran Khan
Dr.Imran Khan
Complete thread:
- Statistical Issue (significant Formulation, Period and seq.)Imran 2007-04-20 07:22 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Statistical Issue (significant Formulation, Period and seq.) usfda_emea 2007-05-05 09:12
- significant Formulation and Period effects Helmut 2007-05-07 14:42
- Statistical Issue (significant Formulation, Period and seq.) Dipesh Jayswal 2007-05-10 13:22
- normalised Cmax Imran 2007-05-25 13:08
- normalised Cmax Helmut 2007-06-30 14:57
- normalised Cmax Imran 2007-05-25 13:08
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