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).
药物临床研究必须经国家药品监督管理局批准后实施,必须执行《药物临床试验质量管理规范》。
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of drugs.
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