Links a CTD table-of-contents heading to the document(s) placed under it. Module 1 codes are regionally defined; Modules 2-5 are ICH-defined.
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HA Controlled Vocabulary
Controlled Vocabulary / Code System Name as defoined by the Health Authority
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Term
Term Description as defined by the Health Authority
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Code
Code, if any, associated with the term by the Health Authority
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Agency
Name of the issuing Health Authority (abbreviation) that maintains the term and code
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Status
Current status of the Term usage as defined by the Health Authority (e.g., Current, Retired, Deprecated)
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|---|---|---|---|---|
| ICH Context of Use | m5.2 tabular listing of all clinical studies |
ich_5.2
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ICH | Active |
| ICH Context of Use | m4.3 literature references |
ich_4.3
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.7 other |
ich_4.2.3.7.7
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.6 impurities |
ich_4.2.3.7.6
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.5 metabolites |
ich_4.2.3.7.5
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.4 dependence |
ich_4.2.3.7.4
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.3 mechanistic studies |
ich_4.2.3.7.3
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.2 immunotoxicity |
ich_4.2.3.7.2
|
ICH | Active |
| ICH Context of Use | m4.2.3.7.1 antigenicity |
ich_4.2.3.7.1
|
ICH | Active |
| ICH Context of Use | m4.2.3.6 local tolerance |
ich_4.2.3.6
|
ICH | Active |
| ICH Context of Use | m4.2.3.5.4 studies in which the offspring juvenile animals are dosed and/or further evaluated |
ich_4.2.3.5.4
|
ICH | Active |
| ICH Context of Use | m4.2.3.5.3 prenatal and postnatal development, including maternal function |
ich_4.2.3.5.3
|
ICH | Active |
| ICH Context of Use | m4.2.3.5.2 embryofetal development |
ich_4.2.3.5.2
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ICH | Active |
| ICH Context of Use | m4.2.3.5.1 fertility and early embryonic development |
ich_4.2.3.5.1
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ICH | Active |
| ICH Context of Use | m4.2.3.4.3 other studies |
ich_4.2.3.4.3
|
ICH | Active |
| ICH Context of Use | m4.2.3.4.2 short or medium-term studies |
ich_4.2.3.4.2
|
ICH | Active |
| ICH Context of Use | m4.2.3.4.1 long-term studies |
ich_4.2.3.4.1
|
ICH | Active |
| ICH Context of Use | m4.2.3.3.2 in vivo |
ich_4.2.3.3.2
|
ICH | Active |
| ICH Context of Use | m4.2.3.3.1 in vitro |
ich_4.2.3.3.1
|
ICH | Active |
| ICH Context of Use | m4.2.3.2 repeat-dose toxicity |
ich_4.2.3.2
|
ICH | Active |
| ICH Context of Use | m4.2.3.1 single-dose toxicity |
ich_4.2.3.1
|
ICH | Active |
| ICH Context of Use | m4.2.2.7 other pharmacokinetic studies |
ich_4.2.2.7
|
ICH | Active |
| ICH Context of Use | m4.2.2.6 pharmacokinetic drug interactions |
ich_4.2.2.6
|
ICH | Active |
| ICH Context of Use | m4.2.2.5 excretion |
ich_4.2.2.5
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ICH | Active |
| ICH Context of Use | m4.2.2.4 metabolism |
ich_4.2.2.4
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ICH | Active |
Showing 26–50 of 380 terms . Data sourced from public health authority publications and updated periodically.