Download or read book Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing written by Harry Yang and published by CRC Press. This book was released on 2016-11-30 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.