Back to the Top
Dear all,
I am interested in what kind of documentation that commonly is kept
for the record after an NCA using WinNonlin as part of a pivotal
bioequivalence study.
Regards,
Johan
Back to the Top
The following message was posted to: PharmPK
Hi Johan,
You need to take printouts of the concentration-time data entered into
WinNonlin, the bioequivalence output, descriptive statistics, PK
output which gives you the Cmax, AUC, Tmax etc.
You need to sign and date on each page.
If you are using SAS for your BE calculations, then you need not put
WinNonlin output.
Hope it helps
Regards
Tausif Ahmed, Ph.D.
Sai Advantium Pharma Ltd., Pune, india
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 "Documentation of NCA" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)