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Pharmaceutical Quality by Design: Principles and Applications

ISBN: 9780128157992 ;ISBN: 0128157992 ;EISBN: 9780128163726 ;EISBN: 0128163720 ;DOI: 10.1016/B978-0-12-815799-2.09991-3 ;OCLC: 1090800279

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  • Title:
    Pharmaceutical Quality by Design: Principles and Applications
  • Author: Beg, Sarwar ; Hasnain, Saquib
  • Subjects: Drugs-Quality control
  • Description: 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 readersIncludes contributions from global leaders and experts from academia, industry and regulatory agencies
  • Publisher: San Diego: Elsevier Science & Technology
  • Creation Date: 2019
  • Format: 450
  • Language: English
  • Identifier: ISBN: 9780128157992
    ISBN: 0128157992
    EISBN: 9780128163726
    EISBN: 0128163720
    DOI: 10.1016/B978-0-12-815799-2.09991-3
    OCLC: 1090800279
  • Source: ScholarVox International
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