中文摘要：

药物治疗是目前唯一有效治疗艾滋病的手段,而我国至今尚无自主知识产权的抗HIV药物上市,药物研发的任务紧迫且艰巨。药物的临床前药效学评价对后续的临床实验具有重要的指导意义。该文以Etravirine为例,介绍和讨论FDA抗HIV药物的临床前药效学评价指导原则,分析了抗HIV药物临床前药效学研究部分的实验要点和重点,希望为完善符合我国国情的抗HIV药物临床前研究标准提出参考。

英文摘要：

Drug treatment is the only way to treat AIDS currently.However,up to now there is still no anti-HIV drugs with independent intellectual property in China,so that developing new anti-HIV products is imperative.Because preclinical studies can provide evidences and datum for clinical studies,it is essential to conduct preclinical pharmacodynamic studies before the initiation of clinical studies.In this review,etravirine is used as an example to introduce the U.S.FDA’s guidance of the anti-HIV drug,and to discuss the different phases and the main points of the preclinical studies,which is expected to contribute to the preclinical studies of anti-HIV drug of China.