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目的对仿制药上市后生物利用度监测与再评价的必要性进行列举,并就应对策略进行阐述,以供医药学工作者借鉴与参考。方法对我国仿制药在前期研发、临床试验、生产等诸多方面存在的问题进行分析。结果与结论我国仿制药的质量参差不齐,有必要进行生物利用度的监测与再评价。国家药政部门、药品检验机构、药品生产企业、临床医生、临床药理工作者等应对此引起高度关注,加强药品的自检、抽检、筛查和监督管理,在进行仿制药上市后生物利用度监测与再评价研究的工作中各尽其能,发现存在问题的药物品种,提高我国仿制药研发技术水平。
Objective To list the necessity of monitoring and re-evaluating the bioavailability after the listing of generic drugs, and to explain the coping strategies for reference of the medical and pharmaceutical workers. Methods Analyze the existing problems in many aspects such as pre-development, clinical trials and production in China. Results and Conclusion The quality of generic drugs in our country is uneven, so it is necessary to monitor and re-evaluate the bioavailability. National drug administrations, drug testing agencies, drug manufacturers, clinicians, clinical pharmacists and other workers should pay close attention to this and strengthen the self-examination, sampling, screening and supervision of pharmaceuticals. After the listing of generic drugs, the bioavailability Monitoring and re-evaluation of the work done their best, found that the existence of the drug varieties, improve China’s generic drug research and development technology.