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。
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.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2006年第12期1437-1439,1440,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
