Statistical Methods for CMC Comparability Studies
The FDA comparability guidance (1996) recognized the need for manufacturers to improve manufacturing processes and analytical methods without performing additional...
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Right First Time for Tablet Disintegration and Dissolution Interplay between Formulation and Dosage Form Microstructure
One of the main performance criteria of a solid oral dosage form is that it is intended to possess a specific dissolution profile. In common industrial practice, the...
Attribute Based Control Strategies for Raw Materials Used to Manufacture Pharmaceuticals
Raw materials are a fundamental element in the manufacturing of biopharmaceuticals that can impact the performance of the manufacturing process and resulting product...