Pharmaceutical Quality by Design: Principles and Applications

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. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma, and biotechnology industry for developing high quality robust productsProvides helpful illustrations, practical examples, and research case studies to explain QbD concepts to the readersIncludes 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 INDICE: 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

• ISBN: 978-0-12-815799-2
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 300
• Fecha Publicación: 01/06/2019
• Nº Volúmenes: 1
• Idioma: Inglés