Bookedited by Walkiria S. Schlindwein, Mark Gibson.
Contents:
Front Matter
Introduction to Quality by Design (QbD) / Bruce Davis, Walkiria S Schlindwein
Quality Risk Management (QRM) / Noel Baker
Quality Systems and Knowledge Management / Siegfried Schmitt
Quality by Design (QbD) and the Development and Manufacture of Drug Substance / Gerry Steele
The Role of Excipients in Quality by Design (QbD) / Brian Carlin
Development and Manufacture of Drug Product / Mark Gibson, Alan Carmody, Roger Weaver
Design of Experiments / Martin Owen, Ian Cox
Multivariate Data Analysis (MVDA) / Claire Beckett, Lennart Eriksson, Erik Johansson, Conny Wikström
Process Analytical Technology (PAT) / Line Lundsberg-Nielsen, Walkiria S Schlindwein, Andreas Berghaus
Analytical Method Design, Development, and Lifecycle Management / Joe Sousa, David Holt, Paul A Butterworth
Manufacturing and Process Controls / Mark Gibson
Regulatory Guidance / Siegfried Schmitt, Mustafa A Zaman
Index
Supplemental Images.