Lytton-Jean Abigail K R, Kauffman Kevin J, Kaczmarek James C, Langer Robert
David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, 02139, USA.
Cancer Treat Res. 2015;166:293-322. doi: 10.1007/978-3-319-16555-4_13.
To be legally sold in the United States, all drugs must go through the FDA approval process. This chapter introduces the FDA approval process and describes the clinical trials required for a drug to gain approval. We then look at the different cancer nanotherapeutics and in vivo diagnostics that are currently in clinical trials or have already received approval. These nanotechnologies are catagorized and described based on the delivery vehicle: liposomes, polymer micelles, albumin-bound chemotherapeutics, polymer-bound chemotherapeutics, and inorganic particles.
要在美国合法销售，所有药物都必须经过美国食品药品监督管理局（FDA）的批准程序。本章介绍了FDA的批准程序，并描述了药物获得批准所需的临床试验。然后，我们将着眼于目前正在进行临床试验或已获批准的不同癌症纳米治疗药物和体内诊断方法。这些纳米技术根据递送载体进行分类和描述：脂质体、聚合物胶束、白蛋白结合型化疗药物、聚合物结合型化疗药物和无机颗粒。
