Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
Author | : Harry Yang |
Publisher | : CRC Press |
Total Pages | : 278 |
Release | : 2016-11-30 |
ISBN-10 | : 9781315354453 |
ISBN-13 | : 1315354454 |
Rating | : 4/5 (454 Downloads) |
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 278 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.