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Optimal handling of Highly Active Pharmaceutical Ingredients during milling and blending operations
(Massachusetts Institute of Technology, 2013)
This thesis investigates best practices for Highly Active Pharmaceutical Ingredient (HAPI) milling and blending. We utilize a qualitative analysis centering on a benchmarking study and quantitative analyses using a ...
Process Analytical Technology in biopharmaceutical manufacturing
(Massachusetts Institute of Technology, 2013)
Process Analytical Technology (PAT) became a well-defined concept within the pharmaceutical industry as a result of a major initiative by the FDA called "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." ...