FHIR IG analytics| Package | hl7.fhir.us.pq-cmc-fda |
| Resource Type | Bundle |
| Id | Bundle-SpecificationProductBundle.json |
| FHIR Version | R5 |
No resources found
No resources found
No narrative content found in resource
FHIR
FHIRsmith{
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_d332acdf-4874-407b-9950-528f14c6bea2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2</b></p><a name=\"d332acdf-4874-407b-9950-528f14c6bea2\"> </a><a name=\"hcd332acdf-4874-407b-9950-528f14c6bea2\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification</a></p></div><p><b>identifier</b>: ExampleSpecification</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.1}\">m3.2.p.5.1 specification(s)</span></p><p><b>date</b>: 2023-12-15 22:33:13+0000</p><p><b>author</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Quality Specification for an example Drug Product</p></div>"
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"author": [
{
"reference": "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
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"title": "Quality Specification for an example Drug Product",
"section": [
{
"title": "32P51",
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_aa514363-d43f-4052-b44e-b67aa4d6dee7\"> </a>\n<div>\n <table class=\"grid dict\">\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">aa514363-d43f-4052-b44e-b67aa4d6dee7</td>\n </tr>\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Version: </b></th>\n <td style=\"padding-left: 4px;\">1.0</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>ExampleSpecification</span>\n </p>\n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Title: </b></th>\n <td style=\"padding-left: 4px;\">Quality Specification for OXAZEPAM</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Type: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>workflow-definition</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Workflow Definition</span>\n </p>\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>C134021</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Drug Product</span>\n </p>\n \n \n \n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Subject: </b></th>\n \n \n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <b>reference: </b> <span>urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9</span>\n </p>\n \n \n \n </td>\n \n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Date: </b></th>\n <td style=\"padding-left: 4px;\">2022-12-08</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Actions: </b></th>\n <td style=\"padding-left: 4px;\">\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b>Single Stage Spectrophotometry Identification:</b> <div><p>Alternate</p>\n</div>\n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Identity - Ferric Chloride:</b> <div><p>Alternate</p>\n</div>\n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Loss on Drying:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Readily Carbonizable Sub:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Residue on ignition (Ash):</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Substances insoluble in sodium carbonate TS:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Impurities - Chloride (Cl):</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Impurities - Sulfate (SO4):</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Elemental Impurities - Limits:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Limit of Free Salicylic Acid:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Organic Volatile Impurities:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Single Stage Assay Dry Basis:</b> \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b> Dissolution - 30 minute:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b>Stage 1 :</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Stage 2 :</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Stage 3 :</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n </table>\n </td>\n </tr>\n \n </table>\n</div>\n</div>"
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9</b></p><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"hc89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-drug-product-handle.html\">Drug Product Handle</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25158}\">CAPSULE</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">OXAZEPAM</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">PROPRANOLOL HYDROCHLORIDE</span></p></blockquote></blockquote></div>"
},
"identifier": [
{
"value": "Example2BeadDrug"
}
],
"combinedPharmaceuticalDoseForm": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C25158",
"display": "CAPSULE"
}
]
},
"route": [
{
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C38288",
"display": "ORAL"
}
]
}
],
"name": [
{
"productName": "OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg",
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C96971",
"display": "Nonproprietary Name"
}
],
"text": "Non-Proprietary"
},
"part": [
{
"part": "OXAZEPAM",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "SCI"
}
]
}
},
{
"part": "30mg",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "STR"
}
],
"text": "OXAZEPAM"
}
},
{
"part": "PROPRANOLOL HYDROCHLORIDE",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "SCI"
}
]
}
},
{
"part": "60mg",
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code": "STR"
}
],
"text": "PROPRANOLOL HYDROCHLORIDE"
}
}
]
}
]
}
},
{
"fullUrl": "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
"resource": {
"resourceType": "Organization",
"id": "4f3e9af1-306b-4fad-bf04-7881400b266a",
"meta": {
"profile": [
"http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
},
"identifier": [
{
"type": {
"coding": [
{
"system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code": "C134003",
"display": "DUNS"
}
]
},
"system": "urn:oid:1.3.6.1.4.1.519.1",
"value": "143265222"
}
],
"name": "Wunderwerke",
"contact": [
{
"address": {
"type": "postal",
"text": "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478",
"line": [
"123 Scenic Road"
],
"city": "Bridgeport",
"state": "CT",
"postalCode": "65478",
"country": "USA"
}
}
]
}
}
]
}