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 |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="plandefinition-drug-pq-ex5-stability-study-protocol"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
</meta>
<text>
<status value="extensions"/>
<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>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"/>
<version value="1.0.0-ballot"/>
<title value="Stability Monitoring Program"/>
<type>
<coding>
<system value="http://example.org/fhir/code/planType"/>
<code value="1244588"/>
<display value="Stability Study Protocol"/>
</coding>
</type>
<status value="active"/>
<subjectReference>🔗
<reference
value="MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"/>
</subjectReference>
<date value="2023-12-18T16:00:45+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International - Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
</contact>
<description value="Narrative description of Stability Study"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
<text value="World"/>
</jurisdiction>
<action>
<title
value="Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg"/>
<action>
<title value="Long-Term"/>
<description value="25°C/60% RH"/>
<action>
<title value="Initial"/>
<timingTiming>
<repeat>
<boundsRange>
<low>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</low>
<high>
<value value="0"/>
<unit value="months"/>
<system value="http://unitsofmeasure.org"/>
<code value="mo"/>
</high>
</boundsRange>
<frequency value="1"/>
</repeat>
</timingTiming>
<action>
<title value="XYZ"/>
<definitionCanonical
value="ActivityDefinition/activityLongTerm25XYZ-Initial"/>
</action>
</action>
</action>
</action>
</PlanDefinition>
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
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change