Pharmaceutical Quality by Design
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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…mehr

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Produktbeschreibung
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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Autorenporträt
Sarwar Beg, PhD is currently serving as AMS-DBT Newton International Fellow at University of Central Lancashire, UK, and working in the area of glioblastoma research using targeted nanomedicines. He is also serving as the Assistant Professor at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi. He has over a decade of teaching and research experience in the field of pharmaceutics and biopharmaceutics, especially in the development of novel and nanostructured drug delivery systems using Quality-by-Design paradigms with core expertise in computational pharmaceutics, experimental designs and multivariate statistical techniques. He has authored over 200 publications, 60 book chapters, 15 books, 03 Indian patent applications and H-Index of 40 with over 5400 citations to his credit.