Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
Nov 2016 · CRC Press
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The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.
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Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.
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