In its report “Critical Path Opportunities for Generic Drugs”, the FDA emphasises the need for advances in the field of analytical sciences in order to accelerate the development of generic products. Here, Gurfateh Singh and Paul Kippax of Malvern Instruments highlight techniques that are especially helpful in the de-formulation of complex reference products, focusing on triple detection Size Exclusion Chromatography (SEC) and Morphologically-Directed Raman Spectroscopy (MDRS).
https://international-pharma.com/wp-content/uploads/2014/10/Accelerating.pdf
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Accelerating the Development of Generic Pharmaceuticals: Developing an Analytical Toolkit Suitable for De-Formulating Complex Reference Products
