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药物临床前研制现场核查是药品注册研制现场核查的重要内容之一,主要是对药学研究、药理毒理研究情况进行现场核查。笔者结合全市药物临床前研制现状,对药物临床前研制现场核查要点和核查中发现的问题进行分析总结。
On-site verification of drug pre-clinical development is one of the important contents of on-site verification of drug registration and development, mainly on-site verification of pharmacy research and pharmacology and toxicology research. The author combines the city’s preclinical development of the status quo, the pre-clinical drug development site verification points and verification of the problems found in the analysis and summary.