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Exploring sources of variability related to the clinical translation of regenerative engineering products : proceedings of a workshop [electronic resource]

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Data Type : eBook
ISBN : 9780309489102 
ISBN : 0309489105 
ISBN : 9780309489126 
ISBN : 0309489121 
ISBN :
ISBN :
ISBN :
ISBN :
Personal Author : Hackmann, Meredith, rapporteur.
Title/Author : Exploring sources of variability related to the clinical translation of regenerative engineering products  [electronic resource]:  proceedings of a workshop/  Meredith Hackmann, Theresa Wizemann, and Sarah H. Beachy, rapporteurs ; Forum on Regenerative Medicine, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine. 
Imprint : Washington, DC:  the National Academies Press,  2019. 
Format : 1 online resource (xx,111 pages):  color illustrations. 
Note : Includes bibliographical references (pages 85-88). 
Content Note : Introduction and overview -- Sources of variability associated with regenerative therapies : lessons from case studies -- Factors contributing to patient variability -- Addressing variability in donor tissues and cells -- Addressing variability and meeting quality expectations in the manufacturing setting -- Exploring variability and its impact on product regulation and outcomes -- Potential next steps to consider for addressing variability -- References -- Appendixes 
요약 : "The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results. The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop"--Publisher's description 
General Subject Name : Regenerative medicine --  Congresses. -- 
General Subject Name : Regenerative medicine --  Standards --  Congresses. -- 
General Subject Name : Quality control --  Congresses. -- 
General Subject Name : Tissue engineering. -- 
Personal Author : Wizemann, Theresa M., rapporteur.
Personal Author : Beachy, Sarah H., rapporteur.
Organization Author : National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Regenerative Medicine, issuing body.
회의명 : Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products (Workshop)  (2018 :  Washington, D.C.), 
기타형태 저록 : Print version:, 0309489091, 9780309489096
Language English
Original text
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  5. 5. 기타 문의사항은 도서관에 문의 바랍니다.
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