Biomedical Product and Materials Evaluation

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.

Cover image
Title page
Table of Contents
Copyright
List of contributors
Preface
1. Overview of medical device development
Abstract
1.1 Introduction
1.2 Planning
Design history file/design dossier
Device master file
1.3 Design process
1.4 Intellectual property right
1.5 Design verification and validation
1.6 Preclinical evaluation
1.7 Packaging, sterilization, and labeling
1.8 Clinical evaluation and clinical investigations
1.9 Manufacturing
1.10 Regulatory perspective
1.11 Postmarketing surveillance
1.12 Conclusion
References
2. Biomaterials for medical products
Abstract
2.1 Introduction
2.2 Conceptualization of biomaterials
2.3 Evolution and categorization of biomaterials
2.4 Natural biomaterials
2.5 Synthetic biomaterials
2.6 Medical products from biomaterials
2.7 Innovative applications
2.8 New-generation materials and structures
2.9 Upcoming trends and future scope
Acknowledgments
References
3. Evaluation of polymeric biomaterials used as wound care products
Abstract
3.1 Introduction
3.2 Classification of wounds
3.3 Type of wound dressings
3.4 Food and Drug Administration classification of wound care products
3.5 Wound-dressing material characterization
3.6 Toxicokinetic and pharmacokinetic studies and biodistribution studies
3.7 Ethical and regulatory requirements (animals, human, biosafety, chemistry)
3.8 Risk assessments of wound care materials and products
3.9 Conclusion
References
4. Nanofibers: promising wound-healing material with modifiable flexibility
Abstract
4.1 Introduction
4.2 Nanofibers
4.3 Conclusion and future prospects
Acknowledgment
References
5. Three-dimensional bioprinting of tissues and organs
Abstract
5.1 Introduction
5.2 The three-dimensional bioprinting process
5.3 3D bioprinted tissues and organs
5.4 Challenges and future perspective
Acknowledgments
References
6. 3D printed organ for healthcare applications
Abstract
Abbreviations
6.1 Introduction
6.2 3D Bioprinting approaches
6.3 3D printing technologies
6.4 3D printing organs via commercial materials
6.5 3D printing organs via tissue-mimicking materials with personalized compositions
6.6 Organ models with incorporated functionalities
6.7 Applications of 3D-printed organs
6.8 Legal and safety issues
6.9 Perspectives
6.10 Summary
References
7. Overcoming the barriers of two-dimensional cell culture systems with three-dimensional cell culture systems: techniques, drug discovery, and biomedical applications
Abstract
7.1 Cell culture systems
7.2 Characteristics of 2D versus 3D culture systems
7.3 Techniques of the 3D cell culture system
7.4 3D culture in toxicity evaluation: drug discovery and development
7.5 3D culture in biomedical applications
7.6 Future challenges and prospects
Acknowledgments
References
8. Blood-derived products
Abstract
8.1 Introduction
8.2 Different types of blood-derived products
8.3 Plasma-derived products
8.4 Viral inactivation of blood-derived products
8.5 Regulation of blood and blood products
8.6 Conclusion
References
9. Medical products from stem cells
Abstract
9.1 Introduction
9.2 Stem cells for eye diseases
9.3 Stem cells for bone diseases
9.4 Stem cells for cardiovascular diseases
9.5 Clinical trials: regulation
9.6 Clinically approved stem cell products
9.7 Safety concerns
9.8 Conclusion
Conflict of interest
References
10. An overview of legal and regulatory challenges of biological products
Abstract
10.1 Introduction
10.2 Regulation of cell and gene therapy
10.3 Regulation of tissue-based products
10.4 Regulation of nanomedicine
10.5 Biosimilars
References
11. The evolving regulatory framework for next-generation stem cell–based pharmaceutical products
Abstract
11.1 Introduction
11.2 Stem cell–based therapy and pharmaceuticals
11.3 Types of stem cell–based pharmaceuticals
11.4 The regulatory requirement for stem cell–based research and products
11.5 The regulatory framework in the United States
11.6 The regulatory framework in the European Union
11.7 The regulatory framework in Japan
11.8 The regulatory framework in India
11.9 Conclusion
References
12. Regulatory issues in biological products
Abstract
12.1 Introduction
12.2 Regulations of biological products
12.3 FDA regulation of biologicals
12.4 Biological product development process
12.5 National regulations for biological products
12.6 Overview of regulatory requirements for biological products
12.7 Conclusion
Conflict of interest
Data availability
Acknowledgment
References
13. In vitro cytotoxicity and cytocompatibility assays for biomaterial testing under regulatory platform
Abstract
Abbreviations
13.1 Introduction
13.2 Cytotoxicity versus cytocompatibility
13.3 Elements of cytotoxicity test
13.4 Cytotoxicity assays
13.5 Cytocompatibility assays
13.6 Summary
Acknowledgments
References
14. Ethical issues in animal experimentation
Abstract
14.1 Introduction
14.2 Animal welfare and its assessment
14.3 Ethics
14.4 Laws and regulations in animal experimentation
14.5 The science involved in laboratory animal science
14.6 Conclusion
References
15. Product evaluation: cytotoxicity assays
Abstract
15.1 Introduction
15.2 Dye exclusion assays
15.3 Colorimetric assay
15.4 Fluorometric assay
15.5 Luminometric assays
15.6 Conclusions
References
16. Product evaluation: safety and toxicity studies
Abstract
16.1 Introduction
16.2 The necessity of toxicity testing and regulatory approvals and standards
16.3 Toxicology studies
16.4 Conclusions and future perspectives
References
17. Product evaluation: blood compatibility studies
Abstract
17.1 Introduction
17.2 Exposure of the device to the blood
17.3 Factors to be considered before blood-material interaction
17.4 Analysis of blood parameters
17.5 Assessment of device performance
17.6 Conclusions
References
18. Product evaluation: Necropsy and Histopathological methods
Abstract
18.1 Introduction
18.2 Necropsy
18.3 Histotechnology procedures
18.4 Conclusion
References
19. Toxicity studies of biomedical products
Abstract
19.1 Introduction
19.2 Toxicity studies applicable to biological products
19.3 Conclusion
Acknowledgments
Conflict of interest
Data availability
References
20. Alternatives to animal testing: concepts, state of art, and regulations
Abstract
Abbreviations
20.1 Introduction
20.2 Animal testing: pros and cons
20.3 In silico alternative systems
20.4 In chemico alternative systems
20.5 Alternative systems: in vitro cell culture systems
20.6 Alternative systems: ex vivo assay systems
20.7 Regulatory aspects
20.8 Conclusions and outlook
Acknowledgments
References
21. Toxicity testing of natural products using the zebrafish model system
Abstract
21.1 Introduction
21.2 Methods and procedures for toxicity testing of natural products
21.3 Conclusions
Funding sources
References
22. Engineered in vitro models: mimicking in vivo physiology
Abstract
22.1 Overview
22.2 The tissue microenvironment
22.3 Traditional in vitro models: two-dimensional tissue culture
22.4 Three-dimensional cultures
22.5 Regulation for good practices within in vitro models
22.6 Conclusions
References
23. Organ-on-a-chip for toxicity evaluation
Abstract
23.1 Introduction
23.2 Microfluidics
23.3 Organ-on-a-chip
23.4 Application of organ-on-a-chip for toxicity studies
23.5 Absorption, distribution, metabolism, excretion studies by multiorgan-on-a-chip
23.6 Conclusion
Acknowledgments
Conflict of interest
Data availability
References
24. Therapeutic applications of probiotics and its regulatory framework
Abstract
24.1 Introduction
24.2 Characteristics of an ideal probiotic
24.3 Screening and selection of probiotics
24.4 Significance and therapeutic uses of probiotics
24.5 Regulatory aspects of probiotics intended for pharmaceutical applications
24.6 Conclusions and future perspectives
References
25. Microbes as biomedicinal minifactories and medical product evaluation models
Abstract
25.1 Introduction
25.2 Microbial biomedicinal products
25.3 Approaches for microbial product improvement
25.4 Microbial cell factories
25.5 Microbial drug evaluation model
25.6 Factors in microbial drug evaluation model development
25.7 Pathogen detection methods
25.8 Conclusion and future prospects
Acknowledgment
References
26. Neurotoxicity assays
Abstract
26.1 Introduction
26.2 Neurotoxicity assays
26.3 Animal models of neurotoxicity
26.4 Conclusion
Acknowledgments
References
27. Sterilization for biological products
Abstract
27.1 Introduction
27.2 Sterilization methods
27.3 Sterilization of biological products
27.4 Sterilization: residual toxicity
27.5 Effects of improper sterilization
27.6 Conclusion
Acknowledgments
Conflict of interest
Data availability
References
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Biomedical Product and Materials Evaluation

Standards and Ethics

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P.V. Mohanan