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