This review summarizes recent progress performed in the design and application of analytical tools and methodologies using nanomaterials for pharmaceutical analysis, and specifically new nanomedicines at distinct phases of development and translation from preclinical to clinical stages. Over the last 10–15 years, a growing number of studies have utilized various nanomaterials, including carbon-based, metallic nanoparticles, polymeric nanomaterials, materials based on biological molecules, and composite nanomaterials as tools for improving the analysis of pharmaceutical products. New and more complex nanomaterials are currently being explored to influence different stages of the analytical process. These materials provide unique properties to support the extraction of analytes in complex samples, increase the selectivity and efficiency of chromatographic separations, and improve the analytical properties of many sensor applications. Indeed, nanomaterials, including electrochemical detection approaches and biosensing, are expanding at a remarkable rate. Furthermore, the analytical performance of numerous approaches to determine drugs in different matrices can be significantly improved in terms of precision, detection limits, selectivity, and time of analysis. However, the quality control and metrological characterization of the currently synthesized nanomaterials still depend on the development of new and improved analytical methodologies, and the application of specific and improved instrumentation. Therefore, there is still much to explore about the properties of nanomaterials which need to be determined even more precisely and accurately.

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分析纳米科学在制药和生物医学领域的影响：批判性观点

本综述总结了使用纳米材料进行药物分析的分析工具和方法的设计和应用的最新进展，特别是处于不同开发阶段和从临床前到临床阶段转化的新纳米药物。在过去的 10-15 年中，越来越多的研究利用各种纳米材料，包括碳基金属纳米颗粒、聚合物纳米材料、基于生物分子的材料和复合纳米材料作为改进药品分析的工具。目前正在探索新的、更复杂的纳米材料来影响分析过程的不同阶段。这些材料具有独特的性能，可支持复杂样品中分析物的萃取，提高色谱分离的选择性和效率，并改善许多传感器应用的分析性能。事实上，纳米材料，包括电化学检测方法和生物传感，正在以惊人的速度发展。此外，多种确定不同基质中药物的方法的分析性能在精度、检测限、选择性和分析时间方面都可以得到显着提高。然而，目前合成的纳米材料的质量控制和计量表征仍然取决于新的和改进的分析方法的开发，以及特定和改进的仪器的应用。因此，关于纳米材料的特性还有很多需要探索的地方，需要更精确和准确地确定。