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here i have to clear about my doubt by mentioning the interpretation
of brazilian guideline which is listed below.
those who have great experience of brazilian submittion can put their
thoughts on it.
Resolution - RE no 896 of 29 May 2003
sec.3.1.3. neither the exclusion of more than 5% of the study's
subjects nor the lack of over 10% of the values for blood
concentration of the active ingredient from administration of each
drug product per volunteer shall be accepted.
1.if study was conducted for brazil submittion in 40 subject than if
more than 2 subject (5% of the study subject) were drop out than
study is not pass from anviza.
2.if the blood samples per volunteer is 20 than if any subject had
not given his 2 sample or missed than this subject should be consider
as drop out or do not analyse.
question 1: if the subject not wish to participate any time during
the study than he is drop out from the study or might be on the basis
of safety point of view he may be withdrawn from the study and it is
very dificult to maintain 5% ratio and that is not predictable, in
that case how we have to submit the study or compliance with the
given section no.3.1
question 2:the same is applicable for 10 % of value for blood
concentration, during the course of amulatory sample it may be
experience of more that 10 % of sample missing than how can we go
question 3:one another question is arize that if subject is dropout/
withdrawn from the study at clinical stage due to any reason shall we
perform analytical for the same or not?
thanks & regards,
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The said clause 3.1.3 is under the statistical part. We are doing
statistical analysis after drop-out and withdrawn subjects.
Hence If we submit 40 subects fot statistical analysis ( after drop
out / withdrawal), not more than 5 % subjects be excluded as
statistical outlliers, in this example not more than 2 subjects can
be excluded after statistical analysis.
The other part of section is also to be interpreted. In the data
fubmitted for statistical analysis, lack of more than 10 % samples
( in total no of samples , say 20, we should get the results from
95%, 18 samples ) is accepted per volunteer.
The members can also comment / opinion on the above.
Azidus Labaoratories Limited,
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