中国临床药理学杂志
中國臨床藥理學雜誌
중국림상약이학잡지
The Chinese Journal of Clinical Pharmacology
2015年
22期
2275-2278
,共4页
避孕药物%临床试验%临床评价
避孕藥物%臨床試驗%臨床評價
피잉약물%림상시험%림상평개
contraceptive drug%clinical trial%clinical evaluation
避孕药物的临床试验比较特殊,不同于疾病治疗药物. 本文从避孕药物临床研究的总体特点、试验设计、疗效指标、安全性评价、风险/获益评估等多方面对此进行了总结和阐述,并对各国针对避孕药物上市许可的不同要求进行了对比和思考.
避孕藥物的臨床試驗比較特殊,不同于疾病治療藥物. 本文從避孕藥物臨床研究的總體特點、試驗設計、療效指標、安全性評價、風險/穫益評估等多方麵對此進行瞭總結和闡述,併對各國針對避孕藥物上市許可的不同要求進行瞭對比和思攷.
피잉약물적림상시험비교특수,불동우질병치료약물. 본문종피잉약물림상연구적총체특점、시험설계、료효지표、안전성평개、풍험/획익평고등다방면대차진행료총결화천술,병대각국침대피잉약물상시허가적불동요구진행료대비화사고.
The clinical trials of contraceptive drugs are very special, which is different from that of therapeutic drugs.In this paper, regarding the clinical research of contraceptive drugs, the overall characteristics of the trial, design, efficacy, safety evaluation, risk/benefit assessment and other aspects were summarized and described.The different requirements for contraceptive drugs from different countries are also compared.
