Pharmaceutical Quality by Design

Pharmaceutical Quality by Design

Principles and Applications

1st Edition - March 27, 2019

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  • Editors: Sarwar Beg, Md Saquib Hasnain
  • eBook ISBN: 9780128163726
  • Paperback ISBN: 9780128157992

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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 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.

Key Features

  • 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


Pharmaceutical scientists, industrial pharmacists, analytical scientists, biostatisticians, health care professionals and regulatory scientists actively involved in pharmaceutical product and process development, postgraduate students, doctoral and postdoctoral researchers, academic researchers

Table of Contents

  • 1. Introduction to Quality by Design (QbD): Fundamentals, principles
    2. Global regulatory perspectives on Quality by Design in pharma manufacturing
    3. Application of Design of Experiments (DoE) in pharmaceutical product and process optimization
    4. QbD considerations for excipient manufacturing
    5. QbD considerations for analytical development
    6. Application of Quality by Design paradigms for development of solid dosage forms
    7. QbD considerations for topical and transdermal product development
    8. Qbd based development of pharmaceutical parenteral drug products: An overview
    9. Quality by design considerations for product development of dry-powder inhalers
    10. QbD considerations for development of lyophilized products
    11. Application of quality by design approach for hot-melt extrusion process optimization
    12. QbD applications for development of nanopharmaceutical products
    13. Application of QbD principles in nanocarrier based drug delivery systems
    14. Application of QbD framework for development of self-emulsifying drug delivery systems
    15. ‘Quality by Design’ approach for development of multiparticulate drug delivery systems
    16. Application of QbD elements for development of vesicular drug delivery systems
    17. Emergence of quality by design in extraction technology for bioactive compounds
    18. Application of quality by design for the development of biopharmaceuticals


Product details

  • No. of pages: 448
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: March 27, 2019
  • Imprint: Academic Press
  • eBook ISBN: 9780128163726
  • Paperback ISBN: 9780128157992

About the Editors

Sarwar Beg

Sarwar Beg is Assistant Professor at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India. Prior to joining Jamia Hamdard, Dr. Sarwar was worked with Jubilant Generics Limited, Noida, as Research Scientist and was responsible for QbD implementation in formulation and analytical development of generic products. He has over a decade of experience in the field of pharmaceutics, especially in the systematic development and characterization of novel and nanostructured drug delivery systems employing Quality by Design (QbD), Design of Experiments (DoE) and multivariate statistical approaches. Besides, Dr. Sarwar has good knowledge in applying various other advanced computational tools like drug release kinetic modeling, pharmacokinetic modeling and in vitro/in vivo correlation (IVIVC) approaches for efficient development of drug products. Dr. Beg has participated and presented his research work at several conferences in USA, Canada, China, India, Bangladesh, and has earned several “Best Paper” awards.

Affiliations and Expertise

Assistant Professor, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India

Md Saquib Hasnain

Prof. (Dr.) Md Saquib Hasnain has over 10 years of research experience in the field of drug delivery and pharmaceutical formulation analyses, especially systematic development and characterization of diverse nanostructured drug delivery systems, controlled release drug delivery systems, bioenhanced drug delivery systems, nanomaterials and nanocomposites employing Quality by Design approaches and many more. Till date he has authored over 70 publications in various high impact peer-reviewed journals, more than 100 book chapters and 16 books to his credit. He is also serving as the reviewer of several prestigious journals. Overall, he has earned a highly impressive publishing and cited record in Google Scholar (h-index: 32). He has also participated and presented his research work at over ten conferences in India, and abroad. He was also a member of scientific societies i.e., Royal Society of Chemistry, Great Britain, International Association of Environmental and Analytical Chemistry, Switzerland and Swiss Chemical Society, Switzerland.

Affiliations and Expertise

Professor, Department of Pharmacy, Palamau Institute of Pharmacy, Jharkhand, India

Ratings and Reviews

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  • Bikash J. Tue Jul 06 2021

    Principles of Quality by Design

    One of the excellent book regarding "Concept and applications of QbD" for researchers. All the chapter contents emphasizes the in detail information on Pharmaceutical Quality by Design

  • Md. I. Sat Jun 22 2019


    An outstanding compilation of present regulatory scenario of QbD and its related paradigms. QbD has lot of applications beyond formulation development, and this book has excellently addressed them.

  • Bikash J. Fri Apr 05 2019

    Outstanding book with Innovative Concept in QbD paradigm

    I have gone through all the Chapters of this book. All the Chapters are very much intersting and illustarate in depth concept and applications of QbD in Pharmaceuticals Product Development. Definitely it is helpful for thereaders, analyst or researchers for complete understanding the subject knowledge and immplementing QbD in their research areas.

  • Dr. G. Wed Apr 03 2019

    Excellent book

    This book has covered the basic to advanced concept and application of quality by design in pharmaceutical product development. Additionally, this book has described the QBD application in nanotechnology based product development also. I found this is an excellent book for current research perspective. I am sure this book will help the reader to understand the qbd with its relevant implementation in their research work.