發(fā)簡(jiǎn)信
IP屬地：浙江
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GCP的發(fā)展歷史世界GCP的發(fā)展歷史 第一個(gè)時(shí)期：20世紀(jì)初至60年代壳繁，是藥物從基本無(wú)管理狀態(tài)到藥物臨床試驗(yàn)管理體系逐步形成的時(shí)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(yàn)質(zhì)量管理規(guī)范刷钢，Good Clinical Practice（GCP）是藥物臨床試驗(yàn)全過(guò)程的質(zhì)量標(biāo)準(zhǔn)考蕾，包括方案設(shè)計(jì)辨液、組織實(shí)施靠瞎、監(jiān)查云石、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...