Hall Jennifer B, Dobrovolskaia Marina A, Patri Anil K, McNeil Scott E
SAIC-Frederick Inc., Nanotechnology Characterization Laboratory, Advanced Technology Program, NCI-Frederick, 1050 Boyles St., Bldg. 469, Frederick, MD 21702, USA.
Nanomedicine (Lond). 2007 Dec;2(6):789-803. doi: 10.2217/17435889.2.6.789.
Nanotechnology offers many advantages to traditional drug design, delivery and medical diagnostics; however, nanomedicines present considerable challenges for preclinical development. Nanoparticle constructs intended for medical applications consist of a wide variety of materials, and their small size, unique physicochemical properties and biological activity often require modification of standard characterization techniques. A rational characterization strategy for nanomedicines includes physicochemical characterization, sterility and pyrogenicity assessment, biodistribution (absorption, distribution, metabolism and excretion [ADME]) and toxicity characterization, which includes both in vitro tests and in vivo animal studies. Here, we highlight progress for a few methods that are uniquely useful for nanoparticles or are indicative of their toxicity or efficacy.
纳米技术为传统药物设计、递送和医学诊断带来了诸多优势；然而，纳米药物在临床前开发中面临着相当大的挑战。用于医学应用的纳米颗粒构建体由各种各样的材料组成，其小尺寸、独特的物理化学性质和生物活性常常需要对标准表征技术进行改进。纳米药物的合理表征策略包括物理化学表征、无菌和热原性评估、生物分布（吸收、分布、代谢和排泄[ADME]）以及毒性表征，其中包括体外试验和体内动物研究。在此，我们重点介绍一些对纳米颗粒特别有用或能表明其毒性或疗效的方法的进展。
