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    GCP的发展历史

    世界GCP的发展历史 第一个时期:20世纪初至60年代,是药物从基本无管理状态到药物临床试验管理体系逐步形成的时期 “磺胺酏剂事件”--致使35...

  • GCP的概念与起源

    药物临床试验质量管理规范,Good Clinical Practice(GCP)是药物临床试验全过程的质量标准,包括方案设计、组织实施、监查、稽...

  • ICH-GCP 12.2 Investigational New Drugs(2)

    Contents Part 4: Investigational New Drugs Responsibilities Part 5: Summ...

  • ICH-GCP 12.1 Investigational New Drugs(1)

    Contents Part 1: Introduction Part 2: Phases of Clinical Trials of Inves...

  • ICH-GCP 11.3 Recruitment & Retention(3)

    Contents Part 7: Using Incentives for Study Participation Part 8: What t...

  • ICH-GCP 11.2 Recruitment & Retention(2)

    Contents Part 4: Advertising for Study Participants Part 5: Retention Pa...

  • ICH-GCP 11.1 Recruitment & Retention(1)

    Contents Part 1: Introduction Part 2: Recruitment Part 3: Recruitment St...

  • ICH-GCP 10.2 Roles & Responsibilities(2)

    Contents Part 2: Responsibilities by Role -- 2 Part 3: Summary of Key Po...

  • ICH-GCP 10.1 Roles & Responsibilities(1)

    Contents Part 1: Introduction Part 2: Responsibilities by Role -- 1 Part...

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