Biomedical Product Development: Bench to Bedside
This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory...
| Other Authors: | , , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2020, 2020
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| Edition: | 1st ed. 2020 |
| Series: | Learning Materials in Biosciences
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| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 1. An Introduction to Biomedical Product Development
- 2. Basic Essentials and Applications of Quality Management System (QMS) in Biomedical Sciences
- 3. Principles of Good Laboratory Practice (GLP)
- 4. Design of Experimental Studies in Biomedical Sciences
- 5. Preclinical Studies for Development of Biomedical Products
- 6. Principles of Good Manufacturing Practice (GMP)
- 7.The importance of Cleanroom facility in manufacturing of biomedical products
- 8. Safety concerns and requirement of cell based products for clinical application
- 9. Standards and regulatory frameworks (for cell and tissue based products)
- 10. Principles of Good clinical Practice (GCP)
- 11. Design, performance and monitoring of clinical trials
- 12. Good Clinical Practice: Guidelines and Requirement
- 13. Ethical Considerations of Biomedical Products Development