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.
第三十二条临床研究用药物,应当在符合《药品生产质量管理规范》条件的车间制备。
Article 32 Drugs for use in clinical study shall be prepared in workshops meeting the conditions provided for in the Criterions for the Quality Control of Drug Manufacturing.
从而希望能为我国研究生教育质量管理的科学化、规范化、制度化服务。
Finally, tries to set up postgraduate education quality management system with construction of ISO9000, and expounds each element of it.
从而希望能为我国研究生教育质量管理的科学化、规范化、制度化服务。
Finally, tries to set up postgraduate education quality management system with construction of ISO9000, and expounds each element of it.
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