This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Active as of 2023-12-18 |
{
"resourceType" : "PlanDefinition",
"id" : "plandefinition-drug-pq-ex5-stability-study-protocol",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"plandefinition-drug-pq-ex5-stability-study-protocol\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource PlanDefinition "plandefinition-drug-pq-ex5-stability-study-protocol" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-PlanDefinition-drug-pq.html\">PlanDefinition - Drug PQ</a></p></div><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol</code></p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: Stability Monitoring Program</p><p><b>type</b>: Stability Study Protocol <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (planType#1244588)</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"MedicinalProductDefinition-medicinalproductdefinition-drug-product-pq-ex1.html\">MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1</a></p><p><b>date</b>: 2023-12-18 16:00:45+0000</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International - Biomedical Research and Regulation: <a href=\"http://www.hl7.org/Special/committees/rcrim\">http://www.hl7.org/Special/committees/rcrim</a></p><p><b>description</b>: Narrative description of Stability Study</p><p><b>jurisdiction</b>: World <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (m49.htm#001)</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg</p><blockquote><p><b>action</b></p><p><b>title</b>: Long-Term</p><p><b>description</b>: 25°C/60% RH</p><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
}
],
"url" : "http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol",
"version" : "1.0.0-ballot",
"title" : "Stability Monitoring Program",
"type" : {
"coding" : [
{
"system" : "http://example.org/fhir/code/planType",
"code" : "1244588",
"display" : "Stability Study Protocol"
}
]
},
"status" : "active",
"subjectReference" : {
🔗 "reference" : "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
},
"date" : "2023-12-18T16:00:45+00:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [
{
"name" : "HL7 International - Biomedical Research and Regulation",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
}
]
}
],
"description" : "Narrative description of Stability Study",
"jurisdiction" : [
{
"coding" : [
{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}
],
"text" : "World"
}
],
"action" : [
{
"title" : "Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg",
"action" : [
{
"title" : "Long-Term",
"description" : "25°C/60% RH",
"action" : [
{
"title" : "Initial",
"timingTiming" : {
"repeat" : {
"boundsRange" : {
"low" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
},
"high" : {
"value" : 0,
"unit" : "months",
"system" : "http://unitsofmeasure.org",
"code" : "mo"
}
},
"frequency" : 1
}
},
"action" : [
{
"title" : "XYZ",
"definitionCanonical" : "ActivityDefinition/activityLongTerm25XYZ-Initial"
}
]
}
]
}
]
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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