Biomedical Product and Materials Evaluation
Standards and Ethics
- 1st Edition - January 24, 2022
- Editor: P.V. Mohanan
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 3 9 6 6 - 7
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 2 4 1 7 3 - 8
Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early developme… Read more
Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation.
This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology.
- Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more
- Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies
- Discusses standardization and ethical hurdles in biomedical product development and how to overcome them
Academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production. Researchers and students working and studying in biomedical engineering, biotechnology and toxicology. May be of interest to policy and lawmakers in biomedical and pre-clinical research
1. Materials for medical products
2. Ethical issues in animal experimentation
3. Ethical issues in product development
4. 3D printed organs for healthcare applications
5. Wound care products
6. Blood derived products
7. Medical products from stem cells
8. Decellularised tissue products
9. Combinational products
10. Diagnostic assays as product development
11. Characterization of cells and animals used in experimentation
12. Product evaluation: Cytotoxicity assays
13. Product evaluation: Blood compatibility studies
14. Product evaluation: Microbial studies
15. Product evaluation: Safety and toxicity studies
16. Product evaluation: Histopathological studies
17. 3D printed organs for toxicity assays
18. Organ-on-a-chip for toxicity evaluation
19. In vitro alternative techniques
20. Neurotoxicity assay
21. Regulatory issues in biological products
22. Sterilization for biological products
- Edition: 1
- Published: January 24, 2022
- Language: English
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P.V. Mohanan
Dr. Mohanan FNASc, is the Head of the Division of Toxicology, Sree Chitra Tirunal Institute for Medical Sciences and Technology (Govt. of India). He is a visiting professor and visiting researcher at Toyo University, Japan and a Certified Biological Safety Specialist. Previously, he was a JSPS Post doctoral Fellow at the University of Tsukuba, Japan in the field of Neurotoxicity. He joined Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Govt. of India in 1989 and has spent 33 years of professional life working there. As a toxicologist he has been intimately associated with all the medical devices/technologies developed at SCTIMST. He received the lifetime achievement award from the Society of Toxicology India, for the outstanding contribution in the field of toxicology. He also patented an ELISA kit for the measurement of pyrogenicity. Mohanan made significant contributions for the development of medical device regulations in India. He has authored 231 publications and edited 6 books. Presently he is the secretary general of the Society of Toxicology, India.
Affiliations and expertise
Scientist-G and Head, Toxicology Division, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Govt. of India, IndiaRead Biomedical Product and Materials Evaluation on ScienceDirect