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The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to produce better targeted medicines.
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E1 Clinical Safety for Drugs used in Long-Term Treatment
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E2A - E2F Pharmacovigilance
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E3 Clinical Study Reports
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E4 Dose-Response Studies
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E5 Ethnic Factors
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E6 Good Clinical Practice
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E7 Clinical Trials in Geriatric Population
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E8 General Considerations for Clinical Trials
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E9 Statistical Principles for Clinical Trials
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E10 Choice of Control Group in Clinical Trials
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E11 - E11A Clinical Trials in Pediatric Population
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E12 Clinical Evaluation by Therapeutic Category
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E14 Clinical Evaluation of QT
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E15 Definitions in Pharmacogenetics / Pharmacogenomics
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E16 Qualification of Genomic Biomarkers
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E17 Multi-Regional Clinical Trials
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E18 Genomic Sampling
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E19 Safety Data Collection
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E20 Adaptive Clinical Trials
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E21 Inclusion of Pregnant and Breastfeeding Individuals in Clinical
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E22 General Considerations for Patient Preference Studies
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