發(fā)簡信
IP屬地：內(nèi)蒙古
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GCP的發(fā)展歷史世界GCP的發(fā)展歷史 第一個時期：20世紀(jì)初至60年代，是藥物從基本無管理狀態(tài)到藥物臨床試驗管理體系逐步形成的時期 “磺胺酏劑事件”--致使35...
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GCP的概念與起源
藥物臨床試驗質(zhì)量管理規(guī)范，Good Clinical Practice（GCP）是藥物臨床試驗全過程的質(zhì)量標(biāo)準(zhǔn)，包括方案設(shè)計、組織實施、監(jiān)查、稽...
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ICH-GCP 12.2 Investigational New Drugs（2）
Contents Part 4: Investigational New Drugs Responsibilities Part 5: Summ...
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ICH-GCP 12.1 Investigational New Drugs（1）
Contents Part 1: Introduction Part 2: Phases of Clinical Trials of Inves...
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ICH-GCP 11.3 Recruitment & Retention（3）
Contents Part 7: Using Incentives for Study Participation Part 8: What t...
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ICH-GCP 11.2 Recruitment & Retention（2）
Contents Part 4: Advertising for Study Participants Part 5: Retention Pa...
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ICH-GCP 11.1 Recruitment & Retention（1）
Contents Part 1: Introduction Part 2: Recruitment Part 3: Recruitment St...
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ICH-GCP 10.2 Roles & Responsibilities（2）
Contents Part 2: Responsibilities by Role -- 2 Part 3: Summary of Key Po...
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ICH-GCP 10.1 Roles & Responsibilities（1）
Contents Part 1: Introduction Part 2: Responsibilities by Role -- 1 Part...