Back to the Top
I was looking at the recent FDA guidance doc on this subject - how have
others received this guidance - is this a major issue in industry, is
what's expected clear or do we need more instruction? How does this
relate to ICH (E4) regulations? Has anyone had any involvement working
on the design and analysis of these studies?
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)