摘要
在不同的生产工艺和生产条件下,药品生产质量和风险不同。通过对32家企业生产的奥美拉唑肠溶胶囊进行含量波动等9个风险因素的评价,确立了综合风险评价系统,为药品监管提供更有针对性的监管目标。
The manufacturing quality and risk of drug is different,because the manufactring process and environment is different.This paper establishes the integrated risk evaluation system by evaluating 9 risk factors including concentration fluctuations of Omeprazole Enteric-coated Capsules through 32 factories＇ products.The purpose of this system is to provide the directed supervision object for government.
出处
《中国药物警戒》
2011年第2期97-99,共3页
Chinese Journal of Pharmacovigilance
关键词
奥美拉唑肠溶胶囊
生产质量
风险评价
omeprazole enteric-coated capsules
manufacturing quality
risk evaluation
