The International Council for Harmonisation (ICH): 'E' group of guidelines
Below is the overview of 'E' group of ICH guidelines that collectively apply to different stages and types of pre- / clinical research and development.
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ICH: ‘E’ group of guidelines overview
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| General Considerations for Clinical Studies: | |
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Design and Analysis: | E4 Dose-Response Studies |
| E9 Statistical principles for Clinical Trials | |
| E10 Choice of Control Group in Clinical Trials | |
| E17 Multi-Regional Clinical Trials | |
| Conduct and Reporting: | E3 Clinical Study Reports |
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| Safety Reporting: | E1 Clinical Safety for Drugs used in Long-Term Treatment |
| E2A – E2F Pharmacovigilance | |
| E14 Clinical Evaluation of QT | |
| E19 Safety Data Collection | |
|
Populations: | E5 Ethnic Factors |
| E7 Clinical Trials in Geriatric Population | |
| E11 – E11A Clinical Trials in Pediatric Polulations | |
| E12 Clinical Evaluation by Therapeutic Category | |
| Genetics / Genomics | E15 Definitions in Pharmacogenetics/Pharmacogenomics |
| E16 Qualification of Genomic Biomarkers | |
| E18 Genomic Sampling | |
Other EU Guidelines:
Author: European Medicines Agency
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