Abstract Quality by Design (QbD) principles play an increasingly important role in the
pharmaceutical industry. Here, we used an analytical QbD (AQbD) approach to develop a …

Quality by design (QbD) expanded in recent years from pharmaceutical processing into
analytical chemistry. Beyond online process analytical technology, off-line assays including …

Abstract Background Analytical Quality by Design (AQbD) has emerged as a pivotal
paradigm in the realm of analytical chemistry, revolutionizing the approach to method …

Recent pharmaceutical regulatory documents have stressed the critical importance of
applying quality by design (QbD) principles for in-depth process understanding to ensure …

The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …

Capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) is a common analytical
procedure used to quantitate critical quality attributes relating to the purity and glycosylation …

Quality is one of the fundamental criteria in addition to safety and efficacy for any entity to be
qualified and approved as a drug. For ensuring consistency of performance of …

Although quality by design (QbD) is widely accepted and put into practice for chemical
process and formulation development, little attention has been paid to apply it to the …

Quality by design (QbD) is an innovative approach to drug development that has started to
be implemented into the regulatory framework, but currently mainly for chemical drugs. The …

Background: As quality by design (QbD) for pharmaceutical product development is being
expanded to include analytical methods, we applied QbD to the development of antigenicity …