1.1 描述开发和/或使用 体外 评价生物分子从生物材料支架中释放用于TEMPs的测定，实例来自文献 1.2 该指南将涉及不包含接种细胞的支架；一般原则可能仍然适用，但如果细胞是临时工的一部分，则可能需要修改。 1.3 体外 生物分子从基质中的释放评估是筛选生物分子-支架相互作用以及表征和/或质量控制的有价值的工具。 1.4 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.5 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ======意义和用途====== 4.1 欧洲和美国药典提供了用于测量药物分析物释放的测试方法，USP<1001>提供了旨在适用于植入产品的方法。然而，释放生物分子的生物材料支架的表征提出了其他药物或药物释放产品中不存在的独特挑战。 4.2 适当设计的 体外 在生物分子开发的早期阶段，释放试验将是有利的-释放支架用于临时工，以及质量控制，并可能有助于减少动物实验的数量。 4.3 附录X1 提供已发布的列表概述 体外 用装载有生物分子的生物材料支架进行的释放研究。 4.4 的一个目标 体外 放行研究旨在模拟 体内 条件尽可能接近，但具有足够简化的抽象。简化包括两个一般方面:与植入物接触以模拟生理环境的流体或释放介质的量，以及该释放介质的组成。

1.1 To describe general principles of developing and/or using an in vitro assay to evaluate biomolecule release from biomaterials scaffolds for TEMPs, with examples from the literature 1.2 The guide will address scaffolds that do not contain seeded cells; general principles may still apply but may need to be modified if cells are part of the TEMPs. 1.3 In vitro release assessment of biomolecules from matrices is a valuable tool for screening biomolecule-scaffold interactions, as well as characterization, and/or quality control. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 European and U.S. Pharmacopeia provide test methods for measuring release of a drug analyte, and USP <1001> provides a method that is intended to be applicable to implanted products. However, the characterization of biomaterial scaffolds that release biomolecules presents unique challenges not present in other drug or drug-releasing products. 4.2 An appropriately designed in vitro release test would be favorable in the early stage of development of biomolecule-releasing scaffolds for TEMPs, as well as in quality control, and may help to reduce the number of animal experiments. 4.3 Appendix X1 provides a tabulated overview of published in vitro release studies performed with biomaterial scaffolds loaded with biomolecules. 4.4 One goal of in vitro release studies is to simulate the in vivo conditions as closely as possible, but with sufficiently simplifying abstraction. The simplification comprises two general aspects: the amount of fluid or release medium in contact with the implant to simulate the physiological environment, and the composition of that release medium.