摘要
针对Ⅰ期临床耐受性试验的现状,从现行法规和技术要求,并结合工作经验,重点论述了中药Ⅰ期临床试验设计与实施中应注意的问题,尤其是在试验时需要把握的质量控制要点,如知情同意书设计、试验实施过程的质控等。
According to the situation of the phase I clinical tolerance test, from the current regulations and technology, combined with the work experience, the paper focuses that the design and the implementation should pay attention to clinical trials of traditional Chinese medicine in stage I in question, especially the quality control points in the test needs, such as informed consent design, test implementation process quality control.
出处
《辽宁中医药大学学报》
CAS
2013年第8期24-26,共3页
Journal of Liaoning University of Traditional Chinese Medicine
关键词
中药
Ⅰ期临床
设计
实施
traditional Chinese medicine
phase I clinical
design
implementation
