Pharma Focus Asia

Emerging Non-clinical Biostatistics In Biopharmaceutical Development And Manufacturing

Emerging Non-clinical Biostatistics In Biopharmaceutical Development And Manufacturing

Pages: 400

Publisher: Chapman & Hall/CRC

Year of Publication: 2016

Author(s) : Harry Yang

Book Description:


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.


•    Presents the first book to provide a single source of information on statistical advances in the implementation of QbD and risk-based methodologies in pharmaceutical development
•    Appeals to multitude groups from R&D to manufacturing to quality control and regulatory affairs
•    Provides real-life examples, along with sufficient technical detail against a statistical backdrop, to make materials easy to grasp for users with limited statistical knowledge
•    Balances a summary of scientific background with regulatory requirements and current/emerging statistical methods

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