药物安全性评价是指药物非临床安全评价即药物非临床研究,药物非临床研究质量管理规范即GLP。
The safety evaluation of drugs refers to drugs non-clinical safety evaluation, or drugs non-clinical research, whose quality management practices are called Good Laboratory Practice (GLP).
对新药安全性实验实施质量监督检查是药物非临床研究质量管理规范(GLP)赋予质量保证部门(QAU)的重要职责。
Study inspection of preclinical safety evaluation of drug is an important responsibility for quality assurance unit (QAU) with good laboratory practice (GLP).
本文旨在通过对药品非临床研究与ADR监测区别与联系的分析,阐明二者之间的联系,使人们对药品安全性评价加以全面的认识。
This paper analyzed and expressed the relationship and difference between non-clinical trial and ADR monitoring, lead a comprehensive understanding of drug safety evaluation.
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