Pharmaceutical quality by design : a practical approach /
"A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Writte...
| Other Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Hoboken, NJ :
John Wiley & Sons Ltd,
2018.
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| Edition: | First edition. |
| Series: | Advances in pharmaceutical technology.
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| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
| Summary: | "A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines 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 include several examples of applications of QbD in actual practice."--Back cover. |
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| Physical Description: | 1 online resource (xxvi, 337 pages.) |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9781118895238 (electronic bk.) 1118895231 (electronic bk.) |