دانلود کتاب Pharmaceutical quality by design : a practical approach

فهرست مطالب :

Content: 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.