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hello,
I want to know the Reasons for period effect and should I check the
significance of period and treatment(fomulation) interaction effect?
-mrudula.
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Dear Mrudula,
Period effects are used to compare the differences between the
measurements in p1 and p2. However, its worth noting that presence or
absence of period effects does not have a bearing on the comparison
of treatments.
The 'treatment*period' interaction is similar to testing for a
'sequence' effect and both terms are used to test for carryover
effects. Typically, the latter is used and it's significance should
be checked. There is some guidance from TPD and FDA on how to deal
with carryover effects. The presence of carryover effects can
potentially bias the estimate of the treatment difference.
Kind regards,
Nav Coelho
Biostatistician, Biovail Contract Research
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Dear mrudula,
your question is not detailed about for what you are asking for but
in certain cases if in BA/BE if you go for the group study than
period effect should be calculated if the one group washout period is
different than other group.
above that in case of replicate design you have to mesure and
calculate period effect to check the carry over test due to design.
again with if you go for two sequence three period study than its
required for calculation.
four period, two sequence also required for period effect calculation.
this all are based on design and drug.
for noramal BA/BE study for two sequence two period as per drug its
not mendatory to calculate.
you can choose and pick the refence guidance of USFDA statistical
approches for the reference.
i put my thought as per my best knowldge, if any one can else can
more focus answer than please correct me.
regards,
paresh mistry
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