TY  - GEN
AU  - Harry Yang
TI  - Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
SN  - 9781498704168
PY  - 2016///1130
PB  - Chapman and Hall/CRC
N2  - 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
ER  -