Introduction to Quality by Design (QbD) From Theory to Practice
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 pharmac...
| Other Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Singapore
Springer Nature Singapore
2024, 2024
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| Edition: | 1st ed. 2024 |
| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 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