This paper analyses the characteristics of the design for the protocol of phase I tolerance trial which makes nasal cavity spray,skin gel and skin sticking plaster for example.

• 本文结合实际范例分析鼻腔喷雾剂、皮肤外敷剂、皮肤外用贴剂等三种外用中药制剂的人体耐受性试验设计特点。