Quality-By-Design Methodology for Rapid LC Method Development

By Graham Shelver and Richard Verseput

The main goal of this book is to establish what constitutes a bestpractices QbD approach to LC method development. The book containsmany case studies and examples of both risky and QbD-aligned workborrowed from pharmaceutical companies working with large and smallmolecule separations.

It allows the reader to understand why and how QbD applies to LCmethod development and by direct extension the development of allanalytical instrument methods. The book teaches the reader why itis necessary to advance from the traditional univariate(one-factor-at-a-time) approach to method development to a modemmultivariate approach in which the work is done according to QbDprinciples utilizing a statistical experimental designframework.

• Format: Hardcover
• Language: English
• ISBN: 1118343492
• ISBN13: 9781118343494
• Release Date: June 2020
• Publisher: Wiley
• Length: 304 Pages