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RegisterSubject within sequence effects [General Statistics]
Dear Helmut & Co. - Greetings from sunny Ireland! [I promise - it REALLY is sunny!] 
A regulatory authority has asked some questions about a BE study my client performed back in the 1990s. In particular, they have asked that: “From the ANOVA tables, influence of treatment, period and subjects (subjects within sequence & sequence) effects should be submitted and discussed by the applicant”.
This was a standard two-way crossover BE study (properly designed with an adequate washout). All that is available of the statistical analysis are the summary statistics and ANOVA tables. I have had a look at these and see that for all primary parameters, the P values for treatment, period and sequence are non-significant (>0.05). However, again for all primary parameters, the P values for subject (sequence) are highly significant.
Can you tell me what, if anything, this might mean? In fashioning your answer, please take into account that I am a physician and not a statistician (i.e. you will need to confine yourself to words of one or two syllables only!).
A regulatory authority has asked some questions about a BE study my client performed back in the 1990s. In particular, they have asked that: “From the ANOVA tables, influence of treatment, period and subjects (subjects within sequence & sequence) effects should be submitted and discussed by the applicant”.
This was a standard two-way crossover BE study (properly designed with an adequate washout). All that is available of the statistical analysis are the summary statistics and ANOVA tables. I have had a look at these and see that for all primary parameters, the P values for treatment, period and sequence are non-significant (>0.05). However, again for all primary parameters, the P values for subject (sequence) are highly significant.
Can you tell me what, if anything, this might mean? In fashioning your answer, please take into account that I am a physician and not a statistician (i.e. you will need to confine yourself to words of one or two syllables only!).
Complete thread:
- Subject within sequence effectsDr Andrew Leary 2012-05-02 17:48 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject within sequence effects Helmut 2012-05-02 18:31
- Subject within sequence effects ElMaestro 2012-05-02 20:10
- Subject within sequence effects Dr Andrew Leary 2012-05-03 10:20
- Should concentrate on brewing Helmut 2012-05-03 11:46
- Subject within sequence effects Dr Andrew Leary 2012-05-03 10:20
Ing. Helmut Schütz