PharmPK Discussion - Brazil requirement

• On 21 Aug 2007 at 13:01:01, "paresh" (paresh.at.accutestindia.com) sent the message
  

  
  Dear all,
  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
  D.O.U. 06/02/2003
  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.
  
  understanding:
  
  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  of safety point of view he may be withdrawn from the study and it is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
  about it.
  
  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  withdrawn from the study at clinical stage due to any reason shall we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,
  Paresh
  
  

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• On 22 Aug 2007 at 05:56:40, Yegnaraman (ryraman2661.-at-.yahoo.co.in) sent the message
  

  
  Dear Paresh,
  
  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  statistical analysis after drop-out and withdrawn subjects.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.
  
  Thanks
  
  T.R.Yegnaraman
  Azidus Labaoratories Limited,
  Chennai-48.
  
  

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