Pharmaceutical Quality by Design - 1st Edition - ISBN: 9780128157992

Pharmaceutical Quality by Design

1st Edition

Principles and Applications

Editors: Sarwar Beg Md Saquib Hasnain
Paperback ISBN: 9780128157992
Imprint: Academic Press
Published Date: 1st June 2019
Page Count: 300
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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 like nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes Pharmaceutical Quality by Design 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 industry for developing high quality robust products
  • Provides helpful illustrations, practical examples, and research case studies to explain QbD concepts to the readers
  • Includes contributions from global leaders and experts from academia, industry, and regulatory agencies, who are considered pioneers in the application of QbD in diverse pharmaceutical products


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



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© Academic Press 2019
Academic Press
Paperback ISBN:

About the Editor

Sarwar Beg

Dr. Sarwar Beg received his PhD in Pharmaceutical Sciences from Panjab University, Chandigarh, India and completed his Masters in Pharmaceutics from Hamdard University, New Delhi, India. His major areas of research interests include DoE/QbD-based development and characterization of controlled release drug delivery systems and bioenhanced drug delivery systems. To date, he has authored more than 50 publications in various high impact peer-reviewed journals, 10 book chapters, 2 books and 1 Indian patent to his credit. He is also serving as an Editorial Board member for several reputed journals in the field of Pharmaceutical Sciences. Dr Beg has also participated and presented his research work at over ten conferences in India, the United States, Canada, China, Dubai, India,. He has received the “Budding ADME Scientist Award 2013”, “Budding QbD Scientist Award 2014”, “Evonik Award 2015”, and several “Best Paper” awards.

Affiliations and Expertise

Product Development Research, Jubilant Generics Limited, Noida, U.P., India

Md Saquib Hasnain

M Saquib Hasnain, PhD, has over 6 years of research experience in the field of pharmaceutics, 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 as well as development and characterization of polymeric composites, formulation characterization using FTIR, DSC, PXRD, SEM, TEM, HPLC, LC-MS, and many more. He has been continuing PhD in Pharmaceutical Sciences as a UGC-MANF Research Fellow from Shri Venkateshwara University, U.P., India, and have completed Masters in Pharmacy from Biju Patnaik University of Technology, Odisha, India. To date, he has authored over 30 publications in various high impact peer-reviewed journals, 30 book chapters, 4 books and 1 Indian patent application to his credit. He has also served as the reviewer of several prestigious journals Hasnain has also participated and presented his research work at over ten conferences in India and abroad. He is also the member of the Royal Society of Chemistry in Great Britain as well as the International Association of Environmental and Analytical Chemistry and the Swiss Chemical Society in Switzerland

Affiliations and Expertise

UGC-MANF Research Fellow, Department of Pharmacy, Shri Venkateshwara University, Gajraula, U.P., India

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