Library of American University of Madaba
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Pharmaceutical quality by design : a practical approach /
edited by Walkiria S. Schlindwein, Mark Gibson.
- Hoboken, NJ : Wiley, 2018.
- xxvi, 337 p. : ill. ; 26 cm
- Advances in pharmaceutical technology .
Includes bibliographical references and index
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
Available to OhioLINK libraries
9781118895214 1118895215 9781118895238 1118895231
Drugs--Design.
Drugs--Quality control.
Electronic books
615.19 / P536
Includes bibliographical references and index
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
Available to OhioLINK libraries
9781118895214 1118895215 9781118895238 1118895231
Drugs--Design.
Drugs--Quality control.
Electronic books
615.19 / P536