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.

Autorentext
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 13 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 100 publications in various high impact peer-reviewed journals, more than 100 book chapters and 30 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. 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.

Klappentext
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.

Inhalt

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