Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (Qb D) 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 Qb D framework by covering the fundamental principles of Qb D, the current regulatory requirements, and the applications of Qb D 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 Qb D 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 Qb D precepts and fundamental aspects of Qb D implementation in the pharma, biopharma and biotechnology industries- Provides helpful illustrations, practical examples and research case studies to explain Qb D concepts to readers- Includes contributions from global leaders and experts from academia, industry and regulatory agencies
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