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中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (12): 1437-1440.

• 设计·统计·方法 • 上一篇    

临床生物等效试验的项目核算和管理

肖大伟   

  1. 南京医科大学附属南京第一医院I 期临床试验室, 南京 210006, 江苏
  • 修回日期:2006-09-29 出版日期:2006-12-26 发布日期:2020-11-06
  • 作者简介:肖大伟, 男, 硕士, 主任药师, 研究方向:临床药理I 期药物临床试验和药物靶向。Tel:13851719507 E-mail:daweixxiao@yahoo.com.cn

Item charge and the accounting management of bioequivalent trial in human

XIAO Da-wei   

  1. Stage I Clinical Laboratory of the First Hospital of Nanjing, the Nanjing Medical University, Nanjing 210006, Jiangsu,China
  • Revised:2006-09-29 Online:2006-12-26 Published:2020-11-06

摘要: 人体生物等效试验属于药物临床试验范畴,必须遵照国家制定的临床试验质量管理规范和有关规章、规定进行;技术上还要符合相应技术标准和技术指导原则。试验收费应该考虑多种因素, 做到规范合理。

关键词: 临床药物试验, 生物等效试验, 项目收费, 项目管理, 成本核算, 价格管理

Abstract: The bioequivalent test in human belongs to clinical trial range.The medical institutions should strictly carry out the state laws and obey rules and regulations,the good clinical practice, and the interrelated clinical trial international laws.In technology, all clinical activity should try its best to the demand of standard operation procedure and to accord with the different principle of technique guidance and the standards.The items of charge and accounting management should be specification and reasonable.The prices gradually tend to its perfecting system.

Key words: clinical trials phase I, bioequivalenct trial, item charge, cost accounting, price management

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