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Pharmaceutical Quality by Design (A Practical Approach) by Schlindwein, Walkiria S.; Gibson, Mark is a scholarly article available to read on EtoBox.

What is Pharmaceutical Quality by Design (A Practical Approach) about?

A practical guide to Quality by Design for pharmaceutical product developmentPharmaceutical Quality by Design: A Practical Approachoutlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and i

Author

Schlindwein, Walkiria S.; Gibson, Mark

Publisher

John Wiley & Sons, Ltd

Published

2018

Language

EN

ISBN

9781118895221