ABSTRACT
The previous chapter discussed the developments in dissolution
testing during the late 1990s and early 2000s when the focus
was on biorelevant dissolution testing and more specifically the
development of dissolution media that physicochemically mimic
the fluid in the GI tract. These approaches have proved useful
for the development and choice of formulations with improved in
vivo release; however, generally these methods have only provided,
a priori, a qualitative understanding of relative performance of
different formulations. Based on this understanding, developments
in dissolution in the late 2000s and 2010s have focused on two
areas: advanced dissolution testing (also discussed in the previous
chapter) and an area that has become known as “clinically relevant
dissolution testing.” Both of these areas have become the focus of
dissolution testing research as there is a growing recognition for
the need to quantitatively predict product performance in vivo.
It is the latter area, clinically relevant dissolution testing, which
is the focus of this chapter. In terms of the drug development
process/timeline this area becomes most important when the
late stage product has been largely developed/chosen and the
sponsor is preparing for late-stage efficacy studies, submission of
themarketing application (e.g., NDA), and commercial supply. This is
in contrast to biorelevant testing (i.e., testing with media replicating
the GI milieu such as FaSSIF), which has most value in the early
stages of drug development (pre-phase 1 to phase 2) when sponsors
are going through the iterative process of developing formulations
good enough to meet the needs of the early clinical program.
