1.1 描述开发和/或使用 体外 评估TEMP生物材料支架生物分子释放的试验，附文献示例 1.2 该指南将介绍不包含种子细胞的支架；一般原则可能仍然适用，但如果电池是TEMP的一部分，则可能需要修改。 1.3 体外 基质中生物分子的释放评估是筛选生物分子-支架相互作用以及表征和/或质量控制的一个有价值的工具。 1.4 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管限制的适用性。 ====意义和用途====== 4.1 欧洲药典（欧洲药典）以及美国药典（USP）描述了片剂、胶囊、透皮贴片和栓剂的几种溶解和药物释放设置（USP<711>，USP<724>，欧洲药典2.9.3，欧洲药典2.9.4）。然而，到目前为止，还没有标准化的药典 体外试验 已经为提供持续药物释放的肠外剂型（例如植入物）建立了释放试验。 4.2 适当设计的 体外试验 释放试验将有利于TEMP生物分子释放支架的早期开发以及质量控制，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 体外试验 使用负载生物分子的生物材料支架进行释放研究。 4.4 一个目标 体外试验 发布研究是为了模拟 体内 条件尽可能接近，但充分简化抽象。简化包括两个一般方面:与植入物接触以模拟生理环境的液体或释放介质的量，以及释放介质的组成。

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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 4.1 The European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) describe several dissolution and drug release setups for tablets, capsules, transdermal patches and suppositories (USP <711>, USP <724>, Ph. Eur. 2.9.3, Ph. Eur. 2.9.4). However, up to this point no pharmacopoeia standardized in-vitro release test has been established for parenteral dosage forms which provide sustained drug release, for example, implants. 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.