Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing (Chapman & Hall/CRC Biostatistics Series)

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. Content: Section 1. Background -- section 2. Analytical method -- section 3. Process development -- section 4. Manufacturing.