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Pharmaceutical Quality by Design: A Practical Approach

Name: Pharmaceutical Quality by Design: A Practical Approach
Brand: Wiley
SKU: 9781118895207
Price: 106.99 USD
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Contributors:

Walkiria S. Schlindwein (Editor), Mark Gibson (Editor)

Publisher:

Wiley

Binding:

Hardcover

Book Category:

Science, Medical

Book Subcategory:

Chemistry, Pharmacy

Book Topic:

Industrial & Technical

Series:

Advances in Pharmaceutical Technology

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The product is eligible for a complimentary return within 30 days from the date of purchase. Furthermore, individual items are shipped within 24 hours of receiving the order.

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Specifications +

Release Date:

2018-03-19

ISBN 13:

9781118895207

Weight:

0.85 lbs

Size:

9.70 x 6.60 x 1.00 inches

Pages:

368

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product description

Description

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. This important resource:

Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development
Puts the focus on the industrial aspects of the new QbD approach
Includes several illustrative examples of applications of QbD in practice
Offers advanced specialist topics that can be systematically applied to industry

Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

About the Author

Editors

Walkiria S. Schlindwein is Associate Professor of Pharmaceutics at the School of Pharmacy, De Montfort University. Walkiria is the programme leader of two Postgraduate courses in Pharmaceutical Quality by Design.

Mark Gibson is Director of AM PharmaServices Ltd. He is a practicing Pharmaceutical Consultant and was formerly with AstraZeneca.

Pharmaceutical Quality by Design: A Practical Approach

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