Accelerating the Development of Generic Pharmaceuticals: 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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