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目的:通过对药品临床试验管理规范(GCP)中心药房试验用药物的规范化管理,建立GCP中心药房的药物管理模式,从而保证临床试验结果的科学性,可靠性,真实性。方法:针对GCP实施中存在的质量问题,对GCP中心药房成立前后的药物管理进行分析比较,以确定试验用药物的管理在GCP实施中所起的作用。结果:GCP中心药房的系列管理大大促进了中心临床试验质量水平的提高。结论:按GCP要求对试验用药物进行规范化管理,为GCP的实施提供了有力的保障。
OBJECTIVE: To establish the drug management model of pharmacy in GCP center through the standardized management of pharmacy trial drugs in GCP center so as to ensure the scientific, reliability and authenticity of clinical trial results. Methods: According to the quality problems existing in the implementation of GCP, the drug administration before and after the establishment of GCP central pharmacy was analyzed and compared to determine the role of the administration of experimental drugs in the implementation of GCP. Results: The series management of GCP Central Pharmacy greatly facilitated the improvement of the quality of central clinical trials. Conclusion: The standardized management of experimental drugs according to GCP requirements provides a strong guarantee for the implementation of GCP.