Harry Yang 
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing [PDF ebook] 

The premise of Quality by Design (Qb D) 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 Qb D 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 Qb D implementation.