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Pharmaceutical Quality by Design

Principles and Applications

Format: Paperback / softback
Publisher: Elsevier Science Publishing Co Inc, San Diego, United States
Imprint: Academic Press Inc
Published: 29th Mar 2019
Dimensions: w 152mm h 229mm
Weight: 800g
ISBN-10: 0128157992
ISBN-13: 9780128157992
Barcode No: 9780128157992
Synopsis
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, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book 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.

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