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Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence

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Changning Guo from the Office of Pharmaceutical Quality discusses new microscopy methods that provide high resolution analysis of particle morphology and can be used in combination of spectral analysis methods to characterize and discriminate between different chemical species of particles or distribution of drug particulates in complex drug products.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Phone - (301) 796-6707 I (866) 405-5367