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Accelerating the development of generic pharmaceuticals

In this article, triple detection SEC and MDRS are considered within the context of characterizing complex drug formulations, with specific case studies and results illustrating their application.

09/06/2016

Developing an Analytical Toolkit Suitable for De-formulating Complex Reference Products In its report ‘Critical Path Opportunities for Generic Drugs’, the FDA emphasizes the need for advances in the field of analytical sciences in order to accelerate the development of generic products. Here, Paul Kippax highlights techniques that are especially helpful in the deformulation of complex reference products, focusing on triple detection Size Exclusion Chromatography (SEC) and Morphologically-Directed Raman Spectroscopy (MDRS).

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