Back to the Top
Hi
I would like to know about the Internal area variation. Can you
inform me about how much percentage variation we should take. is it
ok if we take 50 % variation.
Regards
Vandana Yadav
Back to the Top
The following message was posted to: PharmPK
Dear vandana yadav,
as of my knowledge, There is no standard template for ICF. the ICF is
prepared to meet the various GCP and clinical requirements. the
objective
of ICF is to undarstand the procedures of the study for participant
and also
judge whether to participate or not.
the details such as the Name, Age, may not requiered in ICF once we have
complete details of volunteer/subject in our data base. However, your
ICF
template has such type of details, volunteer should be filled all the
details. Because he should give the consent for participation in the
study.
If any corrections in the filling of ICF, it correction can be done
by the
person who has filled teh ICF.
with regards,
Srinivasa Reddy.E
Research Analyst
Pharmacokinetics and Statistics
Back to the Top
The following message was posted to: PharmPK
Hi all,
It seems to be a too big variation but I think there is no specification
about the internal variation percentage.
I think that your compound have the same variation.
This variation could be problematic for sample near the limit of
quantification and it will be difficult for you to check if your
analysis
goes well (low internal standard variability is a criteria for that).
To conclude, in my opinion, you should try to determine what the reasons
for this variation are. Have a look at your method (extraction,
injection
volume variability and detection parameters) and tell us your
conclusions.
Fabrice Guillet
Biopredic
Saint Gregoire
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)