03664nam a22005055i 4500 978-981-99-8034-5 DE-He213 20251030111812.0 cr nn 008mamaa 240409s2024 si | s |||| 0|eng d 9789819980345 978-981-99-8034-5 10.1007/978-981-99-8034-5 doi RS400-431 PSB bicssc SCI013040 bisacsh PNB thema Introduction to Quality by Design (QbD) [electronic resource] : From Theory to Practice / edited by N. K. Jain, Neha Bajwa. 1st ed. 2024. Singapore : Springer Nature Singapore : Imprint: Springer, 2024. XXIV, 493 p. 102 illus., 96 illus. in color. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda 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. 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. Pharmaceutical chemistry. 67843 Drug delivery systems. Pharmaceutics. 67846 Drug Delivery. 69429 Jain, N. K. editor. edt http://id.loc.gov/vocabulary/relators/edt 74951 Bajwa, Neha. editor. edt http://id.loc.gov/vocabulary/relators/edt 74952 SpringerLink (Online service) Springer Nature eBook Printed edition: 9789819980338 Printed edition: 9789819980352 Printed edition: 9789819980369 https://doi.org/10.1007/978-981-99-8034-5 ZDB-2-CMS ZDB-2-SXC 59048 59048