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
7期
642-646
,共5页
况赟%黄洁%金承怀%华烨%阳国平
況赟%黃潔%金承懷%華燁%暘國平
황빈%황길%금승부%화엽%양국평
Ⅰ期临床试验%英国制药工业协会%指导原则%人体试验%风险评估
Ⅰ期臨床試驗%英國製藥工業協會%指導原則%人體試驗%風險評估
Ⅰ기림상시험%영국제약공업협회%지도원칙%인체시험%풍험평고
phase 1 clinical trial%Association The British Pharmaceuti-cal Industry%guidelines%human verification%risk assessment
Ⅰ期临床试验是新药开发从临床前研究进入人体试验的关键一步。发达国家均制定了相应的法规政策和指导原则。英国制药工业协会（ ABPI）发布了2012版Ⅰ期临床试验指导原则，其对Ⅰ期临床试验中重点关注的问题（如风险评估、合同和协议、保密、试验对象及试验用药品等）提供了专业的指导。本文就2012版ABPI Ⅰ期临床试验指导原则进行简要的介绍。
Ⅰ期臨床試驗是新藥開髮從臨床前研究進入人體試驗的關鍵一步。髮達國傢均製定瞭相應的法規政策和指導原則。英國製藥工業協會（ ABPI）髮佈瞭2012版Ⅰ期臨床試驗指導原則，其對Ⅰ期臨床試驗中重點關註的問題（如風險評估、閤同和協議、保密、試驗對象及試驗用藥品等）提供瞭專業的指導。本文就2012版ABPI Ⅰ期臨床試驗指導原則進行簡要的介紹。
Ⅰ기림상시험시신약개발종림상전연구진입인체시험적관건일보。발체국가균제정료상응적법규정책화지도원칙。영국제약공업협회（ ABPI）발포료2012판Ⅰ기림상시험지도원칙，기대Ⅰ기림상시험중중점관주적문제（여풍험평고、합동화협의、보밀、시험대상급시험용약품등）제공료전업적지도。본문취2012판ABPI Ⅰ기림상시험지도원칙진행간요적개소。
Phase 1 clinical trials is a key step for new drugs from basic experiments to human verification.Developed countries have formulated the corresponding laws , regulations and policies and guiding principles.Association The British Pharmaceutical Industry ( ABPI ) released a 2012 version of guidelines for phase 1 clinical trials.It provided professional guidances for some important problems in phase 1 clinical trials ( such as risk assessment , contracts and agreements , confidentiality , subjects , in-vestigational medicinal products and so on ).This paper makes a brief in-troduction of guiding principles for phase 1 clinical trials on the 2012 ver-sion of the ABPI.
