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.
ISBN: | 9780367736644 |
Publication date: | 18th December 2020 |
Author: | Harry Yang |
Publisher: | Chapman & Hall/CRC an imprint of CRC Press |
Format: | Paperback |
Pagination: | 386 pages |
Series: | Chapman & Hall/CRC Biostatistics Series |
Genres: |
Pharmaceutical chemistry and technology Epidemiology and Medical statistics Probability and statistics Biology, life sciences |