注射剂I期耐受性临床试验方案设计要点

Main points of design about phase I tolerant clinical trials of injectable preparation

为完善注射剂I期耐受性临床试验各环节的技术要求,从用药剂量、递增方案、疗程、配液的选择、给药方法、随机入组设计、理化结果的判断、人体反应预测等方面总结归纳,提出标准操作步骤。经试验证实能有效保证试验质量。

In order to consummate the various specification in phaseⅠtolerant clinical trials, through using medicine dosage, increasing the dosage plan, the treatmerit course, choosing the fluid, giving the medicine method, stochastically entering the group, the physics and chemistry result judgment, human body responding aspect and so on, we summarize and propose the standard sequence of operation. It proves effective to improve the quality from the clinical trials.