Pharmaceutical Quality by Design

Principles and Applications

By: Beg, Hasnain

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Paperback | 29 March 2019 | Edition Number 1

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448 Pages

Dimensions(cm)
22.23 x 14.61 x 1.91

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Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products like nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes Pharmaceutical Quality by Design a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process.

Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma, and biotechnology industry for developing high quality robust products
Provides helpful illustrations, practical examples, and research case studies to explain QbD concepts to the readers
Includes contributions from global leaders and experts from academia, industry, and regulatory agencies, who are considered pioneers in the application of QbD in diverse pharmaceutical products

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