Maur Michela, Sessa Cristiana
Oncology and Haematology Department, University Study of Modena and Reggio Emilia, Italy.
Hematol Oncol. 2007 Jun;25(2):53-7. doi: 10.1002/hon.808.
First in human phase I trials are an unaviodable gateway to the development of new anticancer therapies. The discovery of target therapies have significantly changed the process of clinical drug development.This short review will focus on the main features including knowledge of biological aspects, methodology and adequacy of design and of performance of early clinical studies.
首次人体I期试验是新型抗癌疗法研发不可避免的必经之路。靶向疗法的发现显著改变了临床药物研发进程。本简短综述将聚焦于主要特征，包括生物学方面的知识、方法以及早期临床研究设计和实施的充分性。
