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 readers
- Includes contributions from global leaders and experts from academia, industry and regulatory agencies
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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
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.
Hasnain, Md Saquib
Dr. Md Saquib Hasnain has over 10 years of research experience in the field of drug delivery and pharmaceutical formulation. He has contributed to over 40 publications in various high-impact peer-reviewed journals, 80 book chapters, and 10 books. He also serves as the associate editorial board member of the Recent Patent on Drug Delivery & Formulation journal.