Stats Snax: Bite-sized Statistical Concepts
Stats Snax is a series of short videos (3 – 15 min) that discuss basic statistical concepts that apply to the pharmaceutical industry, using examples from CMC...
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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...
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...