[个体化抗癌疗法：哪些监管指南？]

[Individualized anticancer therapies: which regulatory guidelines?].

作者信息

Bedairia Naima, Marty Michel

机构信息

Centre des innovations thérapeutiques en oncologie et hématologie, centre hospitalier universitaire Saint-Louis, 1, avenue Claude-Vellefaux, 75010 Paris.

出版信息

Bull Cancer. 2008 Oct;95(10):985-8. doi: 10.1684/bdc.2008.0733.

DOI:10.1684/bdc.2008.0733

PMID:19004730

Abstract

In this review, we will summarize the guidelines on the evaluation of anticancer medicinal products in man and definitions for genomic biomarkers (FDA validated), pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.

摘要

在本综述中，我们将总结关于人体抗癌药品评估的指南以及基因组生物标志物（经FDA验证）、药物基因组学、药物遗传学、基因组数据和样本编码类别的定义。