Chemometric approaches have been increasingly viewed as precious complements to high
performance liquid chromatographic practices, since a large number of variables can be …

Pharmaceutical regulatory bodies increasingly require the implementation of systematic
approaches in pharmaceutical product development. Quality control methods play a key role …

This review presents the Analytical Quality by Design (AQbD) concept, an extension of
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …

The pharmaceutical industry is highly regulated by quality policies. The concept of risk
management is strongly integrated into the quality assurance system to ensure …

In modern process management, the life cycle concept gains more and more importance. It
focusses on the total costs of the process from invest to operation and finally retirement. Also …

Most commonly used analytical technique for determination of active pharmaceutical
ingredients and their impurities in quality control throughout all phases of drug research …

The measurement uncertainty (MU) evaluation is important to ensure the analytical
procedure performance, since the higher the uncertainty value the lower the reliability of the …

A comprehensive strategy involving the use of mixture-process variable (MPV) approach
and Quality by Design principles has been applied in the development of a capillary …

A capillary electrophoresis method for the simultaneous determination of the enantiomeric
purity and of impurities of the chiral drug ambrisentan has been developed following the …

A fast and selective capillary electrophoresis method has been developed for the
simultaneous determination of the antihypertensive drugs captopril and hydrochlorothiazide …