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标题:Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit
时间:2019-05-16 14:26:29
DOI:10.1002/9781118873922.ch2
作者:Randolph, Barbara
摘要:Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unitenvironmental protection agency (EPAfood and drug ...
大小:315 kb
页数:20 PAGES
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目录:
  • 2: Good Laboratory Practice Regulations: Roles of the Study Director, Management, and Quality Assurance Unit
    • 2.1 Introduction and Objectives
    • 2.2 Regulation Attempts Prior to 1930
    • 2.3 Critical Events Leading to Regulations
    • 2.4 Nonclinical Regulation
    • 2.5 The Purpose of GLP Regulation
    • 2.6 Industry Benefits of the GLP
    • 2.7 Requirements of the GLP
    • 2.8 The Role of Management
    • 2.9 The Role of the Study Director
    • 2.10 The Role of the Quality Assurance Unit
    • 2.11 A Brief Word about the Multi-site GLP Study
    • 2.12 GLP Interpretation Guidance
    • 2.13 FDA Concerns and the Future
    • 2.14 Comparing GLP Standards: FDA, EPA, and OECD
    • 2.15 Summary
    • References

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