Pharmaceutical Quality by Design: Principles and Applications

ISBN-13: 9780128157992 / Angielski / Miękka / 2019 / 448 str.

Sarwar Beg; MD Saquib Hasnain

Spis treści

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

O autorze

Sarwar Beg, PhD is currently serving as AMS-DBT Newton International Fellow at University of Central Lancashire, UK, and working in the area of glioblastoma research using targeted nanomedicines. He is also serving as the Assistant Professor at Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi. He has over a decade of teaching and research experience in the field of pharmaceutics and biopharmaceutics, especially in the development of novel and nanostructured drug delivery systems using Quality-by-Design paradigms with core expertise in computational pharmaceutics, experimental designs and multivariate statistical techniques. He has authored over 200 publications, 60 book chapters, 15 books, 03 Indian patent applications and H-Index of 40 with over 5400 citations to his credit. 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.