SECTION IV
Applied Aspects
of Drug Development
Introduction
Having covered in Sections I and II the strictly
clinical, more orthodox aspects of drug develop-
ment, we now turn to some applied aspects. In
general, these reflect relatively modern sophistica-
tions in the development process, compared with,
for example, many types of clinical trial design,
which have been available for decades.
These modern aspects of drug development
are rarely optional. All are crucial for the success
of a product in the marketplace. Several of the
next chapters will also describe methodologies
that also teach us, on new dimensions, about
properties that are intrinsic to drugs. Some (e.g.
pharmaceoeconomics) are also becoming of
increasing importance in the regulatory approval
process.