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
2014年
5期
387-390,396
,共5页
药品上市后再评价%新药Ⅳ期临床试验%具“药品促销倾向”的临床验证试验%新药审批办法%药品注册管理办法
藥品上市後再評價%新藥Ⅳ期臨床試驗%具“藥品促銷傾嚮”的臨床驗證試驗%新藥審批辦法%藥品註冊管理辦法
약품상시후재평개%신약Ⅳ기림상시험%구“약품촉소경향”적림상험증시험%신약심비판법%약품주책관리판법
post-marketing drug evaluation%new drug phase Ⅳclini-cal trial%clinically verified trials having inclination to pharmaceutical promotion%regulations for new drug approval%regulations for registration and management of new drug
本文将新药Ⅳ期临床试验与药品上市后再评价的相关政策背景进行了追溯，对两者的异同点进行了比较，并对存在的问题进行了探讨；同时，对具“药品促销倾向”的临床验证试验的特点进行了阐述，期望通过比较三者的区别，为临床医师与药师等明确临床试验的研究目的与范围、为临床合理用药提供研究数据。
本文將新藥Ⅳ期臨床試驗與藥品上市後再評價的相關政策揹景進行瞭追溯，對兩者的異同點進行瞭比較，併對存在的問題進行瞭探討；同時，對具“藥品促銷傾嚮”的臨床驗證試驗的特點進行瞭闡述，期望通過比較三者的區彆，為臨床醫師與藥師等明確臨床試驗的研究目的與範圍、為臨床閤理用藥提供研究數據。
본문장신약Ⅳ기림상시험여약품상시후재평개적상관정책배경진행료추소，대량자적이동점진행료비교，병대존재적문제진행료탐토；동시，대구“약품촉소경향”적림상험증시험적특점진행료천술，기망통과비교삼자적구별，위림상의사여약사등명학림상시험적연구목적여범위、위림상합리용약제공연구수거。
With the retrospection of the background information of new drug phase Ⅳ clinical trials and post -marketing drug evaluation , this paper compared their similarities and differences and explored the exist-ing problems.Meanwhile , it illustrated the characteristics of clinically verified trials having inclination to pharmaceutical promotion , anticipating helping clinicians and clinical pharmacists clarify the purpose and range of clinical trials, and providing data for clinical rational drug use by dis-tinguishing among new drug phase IV clinical trial , post-marketing drug evaluation and clinical trials having inclination to pharmaceutical promotion.
