Pharmaceutical quality by design : a practical approach. First edition

種類:

電子ブック

責任表示:

edited by Dr. Walkiria S. Schlindwein, Mark Gibson

出版情報:

2018

著者名:

• Schlindwein, Walkiria S.
• Gibson, Mark

シリーズ名:

Advances in pharmaceutical technology ;

ISBN:

9781118895221 [1118895223]    
9781118895214 [1118895215]    
9781118895238 [1118895231]    

注記:

Includes bibliographical references and index.
Description based on print version record and CIP data provided by publisher.
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.

ローカル注記:

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