ABSTRACT
Quality by design (QbD) is a structured approach to the development
and delivery of products, technologies, and processes.1 Histori-
cally, QbD has focused on manufacturing processes and product
attributes, but the underlying principles are now routinely applied
to analytical methods. In this chapter we will define the four main
components of QbD and how the QbD approach can be applied to
developing and validating a dissolution test method that uses UV
spectrophotometry as the analytical measurement.
