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为保证用药安全,药品用于临床后需连续监测其安全性。作者详细、具体地阐述了由公司主办、进行正规评价市售药品安全性研究(SAMM)的指导原则。
To ensure drug safety, drugs need to be continuously monitored for safety after they are used in the clinic. The author elaborates in detail the guidelines that companies sponsor to formally evaluate the SAMM study.