Tissue Engineering Measurands
Tissue Engineering Measurands
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DOI：
10.1021/acsbiomaterials.0c00475
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发表时间：
2020-10-01
影响因子：
5.8
通讯作者：
Simon, Carl G., Jr.
中科院分区：
文献类型：
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作者：
Arora, Deepika;Babakhanova, Greta;Simon, Carl G., Jr.
从计量角度思考组织工程医疗产品 (TEMP) 的特性可能有助于改善研究人员之间的沟通。在 TEMP 的开发生命周期中，许多产品属性是在产品发布的漫长过程中测量的。每个测量的选择旨在确定产品是安全有效的（即成功的）。然而，在讨论产品特性时经常会出现沟通不畅的情况。沟通不畅源于对测量结果的固有假设。 “被测量图表”可以帮助澄清这些假设，以便对每个测量值进行更连贯的讨论。被测量被定义为“要测量的数量或属性”。通过三个案例研究讨论了组织工程测量值，包括“支架中的细胞活力”、“效力”和“生物相容性”。讨论了包括测量模型、定义组织工程被测量和定义不确定性在内的主题，以进一步完善对组织工程被测量的思考。在讨论产品特性时了解这些概念可以加强沟通和战略思维，从而使最终的计划清晰且有目的。
A metrological perspective for thinking about the characterization of tissue engineered medical products (TEMPs) may help improve communication between researchers. During the development lifecycle of a TEMP, many product properties are measured over the long path to a product release. The selection of each measurement is designed to establish that the product is safe and efficacious (i.e., successful). However, there is often miscommunication during discussions of product characterization. The miscommunication stems from inherent assumptions that are made about the measurements. A "measurand chart" can help clarify these assumptions to enable a more coherent discussion of the value of each measurement. A measurand is defined as "the quantity or property intended to be measured". Tissue engineering measurands are discussed in terms of three case studies including "cell viability in a scaffold", "potency", and "biocompatibility". Topics including a measurement model, defining tissue engineering measurands and definitional uncertainty, are discussed to further refine thinking about tissue engineering measurands. Awareness of these concepts while discussing product characterization can enhance communication and strategic thinking so that the resulting plan is clear and purposeful.