In vitro bioequivalence studies for oral solid dose products using the Morphologi ID

The Morphologi® ID can be used to compare material and chemical properties of Active Pharmaceutical Ingredients (APIs) in a drug product using Morphologically-Directed Raman Spectroscopy (MDRS®). Characterizing these properties is an important stage in formulation development, Quality Control and supporting in-vitro bioequivalence studies for ANDA submission. Here, we apply this technology to a comparison of innovator and generic versions of an oral solid dose pharmaceutical product containing two APIs.


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