美国HOPA《临床试验药学服务最佳实践标准》解读

Interpretation of HOPA investigational drug service best practice standards of America

目的为我国临床试验药学服务的发展提供参考。方法对美国血液学/肿瘤学药学协会(HOPA)制定的《临床试验药学服务最佳实践标准》进行解读。结果与结论了解在美国药物临床试验中药学服务的职责和实践标准、药师和技术员在临床试验中的作用,为我国临床试验与ICH接轨打下良好基础。

Objective To provide reference for the development of investigational drug service in China.Methods Interprete HOPA Investigational drug service best practice standards of America.Results&Conclusion The understanding of the responsibility of investigational drug service,the best practice and the role of pharmacist and pharmacy technician will lay a good foundation for our clinical trials to keep connection with ICH.