Systems, methods, and computer-readable media for evaluating microstructural equivalence
Abstract:
A method using high resolution imaging data, artificial intelligence-based quantitative image analytics, and image-based release prediction is disclosed to facilitate the determination of microstructure equivalence between two representative samples, such as pharmaceutical and material products. A computer-implemented method of evaluating microstructural equivalence of samples includes quantitatively comparing corresponding parameters of microstructure feature matrices, such as parameters for particle size distribution, porosity, uniformity of spatial distribution, and release rate of a material phase, to permit evaluating whether the samples meet a microstructural equivalence standard within an error tolerance.
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