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    Pharmaceutical Quality by Design: Principles and Applications
    Unavailable
    Pharmaceutical Quality by Design: Principles and Applications
    Unavailable
    Pharmaceutical Quality by Design: Principles and Applications
    Ebook788 pages12 hours

    Pharmaceutical Quality by Design: Principles and Applications

    By Sarwar Beg

    ()

    Currently unavailable

    Currently unavailable

    About this ebook

    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.

    • Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries
    • Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers
    • Includes contributions from global leaders and experts from academia, industry and regulatory agencies
    LanguageEnglish
    PublisherAcademic Press
    Release dateMar 27, 2019
    ISBN9780128163726
    Unavailable
    Pharmaceutical Quality by Design: Principles and Applications

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