Back to the Top
Dear All
As per Anvisa guideline , for stability experiment , we have to
compare stability samples with freashly prepared samples.
so batch would be of Calibation curve+ freashly prepared QC +
stability QC
My doubt is , do we have to process another Batch QC with freashly
prepared samples as freashly prepared QC samples are prepared at Low
and High QC levels only , medium level is not covered so do we need to
process another 2 sets of QC as batch QC .
thanks in advance
--
Regards,
Gaurav Shah
Back to the Top
I think that you should run : 1 fresh calibration curve, 1 fresh
batch of QC (each level : High, Medium, Low) and your stability QC
batch (High and Low).
Fabrice Guillet
XENOBLIS
France
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "QC level for ANVISA study" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)