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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|---|---|---|---|---|
| Context of Use | Responses to Swissmedic LoQ |
110082
|
SwissMedic | — |
| ICH Context of Use Status | replaced |
obsolete
|
ICH | Active |
| ICH Context of Use Status | no longer relevant |
suspended
|
ICH | Active |
| US CoU Keyword Definition Type | material-id |
us_keyword_definition_type_1
|
FDA | — |
| ICH Context of Use | m5.4 literature references |
ich_5.4
|
ICH | Active |
| ICH Context of Use | m5.3.7 case report forms and individual patient listings |
ich_5.3.7
|
ICH | Active |
| ICH Context of Use | m5.3.6 reports of postmarketing experience |
ich_5.3.6
|
ICH | Active |
| ICH Context of Use | m5.3.5.4 other study reports |
ich_5.3.5.4
|
ICH | Active |
| ICH Context of Use | m5.3.5.3 reports of analyses of data from more than one study |
ich_5.3.5.3
|
ICH | Active |
| ICH Context of Use | m5.3.5.2 study reports of uncontrolled clinical studies |
ich_5.3.5.2
|
ICH | Active |
| ICH Context of Use | m5.3.5.1 study reports of controlled clinical studies pertinent to the claimed indication |
ich_5.3.5.1
|
ICH | Active |
| ICH Context of Use | m5.3.4.2 patient pd and pk/pd study reports |
ich_5.3.4.2
|
ICH | Active |
| ICH Context of Use | m5.3.4.1 healthy subject pd and pk/pd study reports |
ich_5.3.4.1
|
ICH | Active |
| ICH Context of Use | m5.3.3.5 population pk study reports |
ich_5.3.3.5
|
ICH | Active |
| ICH Context of Use | m5.3.3.4 extrinsic factor pk study reports |
ich_5.3.3.4
|
ICH | Active |
| ICH Context of Use | m5.3.3.2 patient pk and initial tolerability study reports |
ich_5.3.3.2
|
ICH | Active |
| ICH Context of Use | m5.3.3.1 healthy subject pk and initial tolerability study reports |
ich_5.3.3.1
|
ICH | Active |
| ICH Context of Use | m5.3.3 3 intrinsic factor pk study reports |
ich_5.3.3.3
|
ICH | Active |
| ICH Context of Use | m5.3.2.3 reports of studies using other human biomaterials |
ich_5.3.2.3
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ICH | Active |
| ICH Context of Use | m5.3.2.2 reports of hepatic metabolism and drug interaction studies |
ich_5.3.2.2
|
ICH | Active |
| ICH Context of Use | m5.3.2.1 plasma protein binding study reports |
ich_5.3.2.1
|
ICH | Active |
| ICH Context of Use | m5.3.1.4 reports of bioanalytical and analytical methods for human studies |
ich_5.3.1.4
|
ICH | Active |
| ICH Context of Use | m5.3.1.3 in vitro in vivo correlation study reports |
ich_5.3.1.3
|
ICH | Active |
| ICH Context of Use | m5.3.1.2 comparative ba and bioequivalence study reports |
ich_5.3.1.2
|
ICH | Active |
| ICH Context of Use | m5.3.1.1 bioavailability study reports |
ich_5.3.1.1
|
ICH | Active |
Showing 1–25 of 380 terms . Data sourced from public health authority publications and updated periodically.