Introduction to Quality by Design (QbD)

This book offers a comprehensive exploration of the Quality by Design (QbD) methodology, guiding readers from theory to practical application with accessible examples. It equips readers with both foundational and advanced knowledge, emphasizing the critical parameters necessary for designing pharmaceutical products that meet the highest quality standards. The book goes beyond theory to demonstrate how to effectively implement QbD principles in various aspects of pharmaceutical research and development, including analytical methods, formulation, and packaging processes. Through a step-by-step approach, it prepares researchers in pharmaceutical sciences, as well as professionals in the pharmaceutical and healthcare industries (including suppliers), to successfully integrate QbD into their work.

Bridges the gap between theory and practice Offers a step-by-step guide to the knowledge and skills required to implement QbD in research and projects Equips readers with practical tools and strategies to improve their product development processes

Auteur
NK Jain is an internationally renowned academician and researcher and a senior professor in India who superannuated in June 2014 after rendering more than 40 years of dedicated and distinguished service as a teacher and 25 years as full professor. Starting his academic career in 1973 he worked as Lecturer in Pharmacy, Holkar College, Indore; Reader in Pharmaceutical Technology. M.S. University, Baroda; Professor and Principal, College of Pharmacy, Nasik; Professor and Head, Department of Pharmaceutical Sciences, Dr. H. S. Gour University, Sagar; Principal, College of Pharmacy, New Delhi; Visiting Professor, Dubai Pharmacy College, Dubai (UAE); and Head, Pharmacy Department, Delhi University. Subsequent to his superannuation, Emeritus Fellow (U.G.C.) at Rajiv Gandhi Technological University, Bhopal, M.P., India. Prof. Jain is the author of two dozen celebrated books in pharmaceutical sciences and has contributed over 60 chapters in national and international books. He has to his credit over 500 publications in reputed pharmaceutical Journals. According to a ranking announced by the Stanford University Scientists, Prof. N.K.Jain is included in top 2% scientists in the world in the area of Pharmacology and Pharmacy, consecutively for 4 years.

Neha Bajwa is presently working as Assistant Professor at University Institute of Pharma Sciences, Chandigarh University, Mohali. She has more than 25 publications in international and national journals with total impact factor 126 including article in Nature materials and Advanced Drug Delivery Reviews. In addition she has been frequent writer at various magazines and newspapers. Presently, she won Young Investigator Training Program to work in University of Turin for six months. She also won travel grant from FIP to attend FIP-PSWC 2020 conference at Montreal, Canada. Currently, she is also Fellow/ Life member of Indian Pharmacy Graduate Associations and the Association of Pharmaceutical Teachers of India. She had attended and presented research papers in more than 20 national and international conferences. She won various best poster research award including 6th world congress on Nanomedical Sciences-ISNSCON-2018 held at VigyanBhawan, New-Delhi. Also she has worked on various govt. agencies like AICTE, UGC, DST, CYCLONET, FIP sponsored projects.

Contenu
Chapter 1. Introduction to Quality by Design.- Chapter 2. Regulatory Aspects of Quality by Design (USFDA, PMDA, ICH, EMEA guidelines).- Chapter 3. Criteria for selection of Design (PAT, CMA,CPA,CQA,RMEA).- Chapter 4. Analytical Quality by Design.- Chapter 5. API Quality by Design.- Chapter 6. Quality by Design for formulation development.- Chapter 7. Quality by Design for oral formulations (tablets, spheroids).- Chapter 8. Quality by Design for topical formulations.- Chapter 9. Quality by Design for parenteral formulations.- Chapter 10. Quality by Design approach for Novel Drug Delivery Systems.- Chapter 11. Quality by Design for herbal products/ formulations.- Chapter 12. Quality by Design in Quality Assurance.- Chapter 13. Quality by Design in pharmaceutical packaging.- Chapter 14. Quality by Design and Clinical Trials.- Chapter 15. Applications of Quality by design.- Chapter 16. Quality by Design and Marketing.- Chapter 17. Conclusions and Future perspective.