Analytical Method Development and Qualification
Analytical methods are intended to establish the identity, purity, physical characteristics and potency of drugs. Methods are developed to support drug testing against speciﬁcations during manufacturing and quality release operations, as well as during long-term stability studies. Methods may also support safety and characterization studies or evaluations of drug performance. According to the International Conference on Harmonization (ICH), the most common types of analytical procedures are: (i) identiﬁcation tests, (ii) quantitative tests of the active moiety in samples of API or drug product or other selected component(s) in the drug product, (iii) quantitative tests for impurity content, and (iv) limits tests for the control of impurities.
At Novabioassays we work with the clients to perform method development in parallel with the evolution of the drug product, mainly focusing on the phase of early drug development. During early drug development the methods may focus on API behavior. They should be suitable to support pre-clinical safety evaluations, pre-formulation studies, and prototype product stability studies. As drug development progresses, the analytical methods are reﬁned and expanded, based on increased API and drug product knowledge. The methods should be robust and uncomplicated, while still meeting the appropriate regulatory guidelines.