标题: 类型:
 ICH指导原则共180条
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标题
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有效性
M7 Addendum
有效性
M3的问与答
有效性
Integrated Addendum to Good Clinical Practice (GCP)
有效性
Implementation_ Electronic Transmission of Individual Case Safety Reports
有效性
Good Clinical Practice (GCP)
有效性
Genomic Sampling and Management of Genomic Data
有效性
General principle on planning_designing Multi-Regional Clinical Trials
有效性
Ethnic Factors in the Acceptability of Foreign Clinical Data
有效性
Dose-Response Information to Support Drug Registration
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Development Safety Update Report
有效性
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
有效性
Clinical Safety Data Management_ Definitions and Standards for Expedited Reporting
有效性
Clinical Safety Data Management_ Data Elements for Transmission of Individual Case Safety Reports
有效性
Clinical Investigation of Medicinal Products in the Pediatric Population
有效性
Choice of Control Group and Related Issues in Clinical Trials
有效性
Biomarkers Related to Drug or Biotechnology Product Development_ Context, Structure and Format of Qualification Submissions
有效性
Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
有效性
Addendum_ Statistical Principles for Clinical Trials
有效性
Addendum_ Clinical Investigation of Medicinal Products in the Pediatric Population
安全性
药物致癌试验的必要性
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