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.
1. Biomedical Product and Materials Evaluation - p. i 2. Cover - p. i 3. Title Page - p. i 4. Copyright - p. iv 5. Table of Contents - p. iv 6. List of contributors - p. xxi 7. Preface - p. xxvii 8. 1 Overview of medical device development - p. 1 9. 2 Biomaterials for medical products - p. 25 10. 3 Evaluation of polymeric biomaterials used as wound care products - p. 63 11. 4 Nanofibers: promising wound-healing material with modifiable flexibility - p. 95 12. 5 Three-dimensional bioprinting of tissues and organs - p. 135 13. 6 3D printed organ for healthcare applications - p. 151 14. 7 Overcoming the barriers of two-dimensional cell culture systems with three-dimensional cell culture systems: techniques, drug discovery, and biomedical applications - p. 179 15. 8 Blood-derived products - p. 231 16. 9 Medical products from stem cells - p. 259 17. 10 An overview of legal and regulatory challenges of biological products - p. 275 18. 11 The evolving regulatory framework for next-generation stem cell–based pharmaceutical products - p. 287 19. 12 Regulatory issues in biological products - p. 309 20. 13 In vitro cytotoxicity and cytocompatibility assays for biomaterial testing under regulatory platform - p. 329 21. 14 Ethical issues in animal experimentation - p. 355 22. 15 Product evaluation: cytotoxicity assays - p. 373 23. 16 Product evaluation: safety and toxicity studies - p. 409 24. 17 Product evaluation: blood compatibility studies - p. 435 25. 18 Product evaluation: Necropsy and Histopathological methods - p. 461 26. 19 Toxicity studies of biomedical products - p. 483 27. 20 Alternatives to animal testing: concepts, state of art, and regulations - p. 501 28. 21 Toxicity testing of natural products using the zebrafish model system - p. 531 29. 22 Engineered in vitro models: mimicking in vivo physiology - p. 555 30. 23 Organ-on-a-chip for toxicity evaluation - p. 611 31. 24 Therapeutic applications of probiotics and its regulatory framework - p. 635 32. 25 Microbes as biomedicinal minifactories and medical product evaluation models - p. 667 33. 26 Neurotoxicity assays - p. 703 34. 27 Sterilization for biological products - p. 725 35. Index - p. 743
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.
1. Biomedical Product and Materials Evaluation - p. i 2. Cover - p. i 3. Title Page - p. i 4. Copyright - p. iv 5. Table of Contents - p. iv 6. List of contributors - p. xxi 7. Preface - p. xxvii 8. 1 Overview of medical device development - p. 1 9. 2 Biomaterials for medical products - p. 25 10. 3 Evaluation of polymeric biomaterials used as wound care products - p. 63 11. 4 Nanofibers: promising wound-healing material with modifiable flexibility - p. 95 12. 5 Three-dimensional bioprinting of tissues and organs - p. 135 13. 6 3D printed organ for healthcare applications - p. 151 14. 7 Overcoming the barriers of two-dimensional cell culture systems with three-dimensional cell culture systems: techniques, drug discovery, and biomedical applications - p. 179 15. 8 Blood-derived products - p. 231 16. 9 Medical products from stem cells - p. 259 17. 10 An overview of legal and regulatory challenges of biological products - p. 275 18. 11 The evolving regulatory framework for next-generation stem cell–based pharmaceutical products - p. 287 19. 12 Regulatory issues in biological products - p. 309 20. 13 In vitro cytotoxicity and cytocompatibility assays for biomaterial testing under regulatory platform - p. 329 21. 14 Ethical issues in animal experimentation - p. 355 22. 15 Product evaluation: cytotoxicity assays - p. 373 23. 16 Product evaluation: safety and toxicity studies - p. 409 24. 17 Product evaluation: blood compatibility studies - p. 435 25. 18 Product evaluation: Necropsy and Histopathological methods - p. 461 26. 19 Toxicity studies of biomedical products - p. 483 27. 20 Alternatives to animal testing: concepts, state of art, and regulations - p. 501 28. 21 Toxicity testing of natural products using the zebrafish model system - p. 531 29. 22 Engineered in vitro models: mimicking in vivo physiology - p. 555 30. 23 Organ-on-a-chip for toxicity evaluation - p. 611 31. 24 Therapeutic applications of probiotics and its regulatory framework - p. 635 32. 25 Microbes as biomedicinal minifactories and medical product evaluation models - p. 667 33. 26 Neurotoxicity assays - p. 703 34. 27 Sterilization for biological products - p. 725 35. Index - p. 743
