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Hello, any one provide inputs about detecting a period affect and
sequence affect during a BE study.
the 'P' value obtained after ANOVA is less than 0.05(at 5% level of
significance) for period affect.
after completion of BE study if the period affect was detected, what
impact it will have on the acceptance of the study by the regulatory
In those cases do we need to provide any justification for having
and in the similar manner, what impact it has on sequence affect and
what are the reasons for getting period and sequence affects.
Thanks in advance,
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