Pharmaceutical Quality by Design

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

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

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