Generated Narrative: MedicinalProductDefinition 3 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #uWv5aQ4vBHUyQ2YS identifier: http://example.org/medicinal-product-identifiers/STELBAT-001 type: bulk description: Stelbat medicinal product for stability testing combinedPharmaceuticalDoseForm: Tablet formulation Names - ProductName * Stelbat
Stelbat medicinal product for stability testing
Generated Narrative: Medication 13 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #x3jr1hrsYz2TpPDK org/fhir/StructureDefinition/batch-type: DS org/fhir/StructureDefinition/packaging-info: Tablets - DS org/fhir/StructureDefinition/medicinal-product: Medicinal Product Definition identifier: http://example.org/batch-identifiers/000232445 code: Stelbat DS Batch 000232445 status: Active Batches - Extension LotNumber ExpirationDate * 000232445 2026-12-31
Generated Narrative: Medication 14 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #BoweGs34kD40efe6 org/fhir/StructureDefinition/batch-type: DS org/fhir/StructureDefinition/packaging-info: Tablets - DS org/fhir/StructureDefinition/medicinal-product: Medicinal Product Definition identifier: http://example.org/batch-identifiers/000232470 code: Stelbat DS Batch 000232470 status: Active Batches - Extension LotNumber ExpirationDate * 000232470 2026-12-31
Generated Narrative: Medication 15 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #rP5Xw3SdYkjV3YW3 org/fhir/StructureDefinition/batch-type: DS org/fhir/StructureDefinition/packaging-info: Tablets - DS org/fhir/StructureDefinition/medicinal-product: Medicinal Product Definition identifier: http://example.org/batch-identifiers/000232490 code: Stelbat DS Batch 000232490 status: Active Batches - Extension LotNumber ExpirationDate * 000232490 2026-12-31
Generated Narrative: Medication 16 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #q6iU7jsInnxB13cG org/fhir/StructureDefinition/batch-type: DP org/fhir/StructureDefinition/packaging-info: Tablets - DP org/fhir/StructureDefinition/medicinal-product: Medicinal Product Definition identifier: http://example.org/batch-identifiers/000345667 code: Stelbat DP Batch 000345667 status: Active Batches - Extension LotNumber ExpirationDate * 000345667 2026-12-31
Generated Narrative: Medication 17 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #GT3jliuvbryWWCYf org/fhir/StructureDefinition/batch-type: DP org/fhir/StructureDefinition/packaging-info: Tablets - DP org/fhir/StructureDefinition/medicinal-product: Medicinal Product Definition identifier: http://example.org/batch-identifiers/000321479 code: Stelbat DP Batch 000321479 status: Active Batches - Extension LotNumber ExpirationDate * 000321479 2026-12-31
Generated Narrative: Medication 18 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #V69kHsXqPQlMqr5c org/fhir/StructureDefinition/batch-type: DP org/fhir/StructureDefinition/packaging-info: Tablets - DP org/fhir/StructureDefinition/medicinal-product: Medicinal Product Definition identifier: http://example.org/batch-identifiers/000375192 code: Stelbat DP Batch 000375192 status: Active Batches - Extension LotNumber ExpirationDate * 000375192 2026-12-31
Generated Narrative: Observation 52 version: 2; Last updated: 2025-06-05 21:38:28+0000; Information Source: #4Y23UT79vCEzmgO2 Tags: cro-provided-result (Details: tags code cro-provided-result), submitted-to-regulator (Details: tags code submitted-to-regulator) org/fhir/StructureDefinition/test-protocol-reference: PlanDefinition/id-4 org/fhir/StructureDefinition/protocol-timepoint: timepoint_0 org/fhir/StructureDefinition/protocol-timepoint-title: Initial org/fhir/StructureDefinition/shared-with-sponsor: true org/fhir/StructureDefinition/parameter-results: {"test_name": "Dissolution (Mean)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "Initial"} org/fhir/StructureDefinition/criteria-results: {"meets_acceptance_criteria": true} org/fhir/StructureDefinition/result-details: {"condition_title": "25\u00b0C/60% RH", "timepoint_title": "Initial", "test_title": "Dissolution (Mean)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"} org/fhir/StructureDefinition/result-source: cro org/fhir/StructureDefinition/submitted-to-regulator: true org/fhir/StructureDefinition/submission-date: Exception Generating Narrative: Text '2025-06-05T21:38:28.529182' could not be parsed at index 26
{"test_name": "Dissolution (Mean)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "Initial"}
{"condition_title": "25\u00b0C/60% RH", "timepoint_title": "Initial", "test_title": "Dissolution (Mean)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"}
Submitted 4 CRO results for regulatory review
25°C/60% RH - Initial - Dissolution (Mean)
Generated Narrative: Observation 53 version: 2; Last updated: 2025-06-05 21:38:28+0000; Information Source: #GsSmwgys263TXKUr Tags: cro-provided-result (Details: tags code cro-provided-result), submitted-to-regulator (Details: tags code submitted-to-regulator) org/fhir/StructureDefinition/test-protocol-reference: PlanDefinition/id-4 org/fhir/StructureDefinition/protocol-timepoint: timepoint_0 org/fhir/StructureDefinition/protocol-timepoint-title: Initial org/fhir/StructureDefinition/shared-with-sponsor: true org/fhir/StructureDefinition/parameter-results: {"test_name": "Dissolution (Conclusion)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "Initial"} org/fhir/StructureDefinition/criteria-results: {"meets_acceptance_criteria": true} org/fhir/StructureDefinition/result-details: {"condition_title": "25\u00b0C/60% RH", "timepoint_title": "Initial", "test_title": "Dissolution (Conclusion)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"} org/fhir/StructureDefinition/result-source: cro org/fhir/StructureDefinition/submitted-to-regulator: true org/fhir/StructureDefinition/submission-date: Exception Generating Narrative: Text '2025-06-05T21:38:28.597096' could not be parsed at index 26
{"test_name": "Dissolution (Conclusion)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "Initial"}
{"condition_title": "25\u00b0C/60% RH", "timepoint_title": "Initial", "test_title": "Dissolution (Conclusion)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"}
25°C/60% RH - Initial - Dissolution (Conclusion)
Generated Narrative: Observation 54 version: 2; Last updated: 2025-06-05 21:38:28+0000; Information Source: #YpyFFPQtdp3qyTUi Tags: cro-provided-result (Details: tags code cro-provided-result), submitted-to-regulator (Details: tags code submitted-to-regulator) org/fhir/StructureDefinition/test-protocol-reference: PlanDefinition/id-4 org/fhir/StructureDefinition/protocol-timepoint: timepoint_1 org/fhir/StructureDefinition/protocol-timepoint-title: 3 months org/fhir/StructureDefinition/shared-with-sponsor: true org/fhir/StructureDefinition/parameter-results: {"test_name": "Dissolution (Conclusion)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "3 months"} org/fhir/StructureDefinition/criteria-results: {"meets_acceptance_criteria": true} org/fhir/StructureDefinition/result-details: {"condition_title": "25\u00b0C/60% RH", "timepoint_title": "3 months", "test_title": "Dissolution (Conclusion)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"} org/fhir/StructureDefinition/result-source: cro org/fhir/StructureDefinition/submitted-to-regulator: true org/fhir/StructureDefinition/submission-date: Exception Generating Narrative: Text '2025-06-05T21:38:28.620076' could not be parsed at index 26
{"test_name": "Dissolution (Conclusion)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "3 months"}
{"condition_title": "25\u00b0C/60% RH", "timepoint_title": "3 months", "test_title": "Dissolution (Conclusion)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"}
25°C/60% RH - 3 months - Dissolution (Conclusion)
Generated Narrative: Observation 55 version: 2; Last updated: 2025-06-05 21:38:28+0000; Information Source: #OEmSWBbbxO1BcMeE Tags: cro-provided-result (Details: tags code cro-provided-result), submitted-to-regulator (Details: tags code submitted-to-regulator) org/fhir/StructureDefinition/test-protocol-reference: PlanDefinition/id-4 org/fhir/StructureDefinition/protocol-timepoint: timepoint_1 org/fhir/StructureDefinition/protocol-timepoint-title: 3 months org/fhir/StructureDefinition/shared-with-sponsor: true org/fhir/StructureDefinition/parameter-results: {"test_name": "Dissolution (Mean)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "3 months"} org/fhir/StructureDefinition/criteria-results: {"meets_acceptance_criteria": true} org/fhir/StructureDefinition/result-details: {"condition_title": "25\u00b0C/60% RH", "timepoint_title": "3 months", "test_title": "Dissolution (Mean)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"} org/fhir/StructureDefinition/result-source: cro org/fhir/StructureDefinition/submitted-to-regulator: true org/fhir/StructureDefinition/submission-date: Exception Generating Narrative: Text '2025-06-05T21:38:28.641157' could not be parsed at index 26
{"test_name": "Dissolution (Mean)", "category": "Dissolution Values", "subcategory": "", "condition": "25\u00b0C/60% RH", "timepoint": "3 months"}
{"condition_title": "25\u00b0C/60% RH", "timepoint_title": "3 months", "test_title": "Dissolution (Mean)", "test_category": "Dissolution Values", "test_subcategory": "", "test_description": "Physico-chemical properties"}
25°C/60% RH - 3 months - Dissolution (Mean)
Generated Narrative: ObservationDefinition 10 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #MWNbtBqbHZ8mr9TF org/fhir/StructureDefinition/stability-test-type: Dissolution Values org/fhir/StructureDefinition/stability-test-description: Physico-chemical properties org/fhir/StructureDefinition/stability-test-subtype: Mean org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"} status: Active code: Dissolution (Mean)
{"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"}
Generated Narrative: ObservationDefinition 11 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #PmIttShFPWhGPIRL org/fhir/StructureDefinition/stability-test-type: Dissolution Values org/fhir/StructureDefinition/stability-test-description: Physico-chemical properties org/fhir/StructureDefinition/stability-test-subtype: Conclusion org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"} status: Active code: Dissolution (Conclusion)
Generated Narrative: ObservationDefinition 12 version: 1; Last updated: 2025-06-05 21:05:52+0000; Information Source: #tVJkwb2gFE9mlea4 org/fhir/StructureDefinition/stability-test-type: Microbial Quality org/fhir/StructureDefinition/stability-test-description: Microbiological Properties org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the Ph Eur"} status: Active code: Microbial Quality
{"Acceptance Criteria": "Shall comply with the requirements of the Ph Eur"}
Generated Narrative: ObservationDefinition 19 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #2Qi45gYASn713bEV org/fhir/StructureDefinition/stability-test-type: Dissolution Values org/fhir/StructureDefinition/stability-test-description: Physico-chemical properties org/fhir/StructureDefinition/stability-test-subtype: Mean org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Dissolution (Mean)
Generated Narrative: ObservationDefinition 20 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #YKNOSEMyEZVA5T74 org/fhir/StructureDefinition/stability-test-type: Dissolution Values org/fhir/StructureDefinition/stability-test-description: Physico-chemical properties org/fhir/StructureDefinition/stability-test-subtype: Conclusion org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Dissolution (Conclusion)
Generated Narrative: ObservationDefinition 21 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #q95Y107xEi04MHQ0 org/fhir/StructureDefinition/stability-test-type: Microbial Quality org/fhir/StructureDefinition/stability-test-description: Microbiological Properties org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the Ph Eur"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Microbial Quality
Generated Narrative: ObservationDefinition 22 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #AAKKMRtRWtNkSXgD org/fhir/StructureDefinition/stability-test-type: Assay org/fhir/StructureDefinition/stability-test-description: Assay org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "95% to 105% of label claim"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Assay
{"Acceptance Criteria": "95% to 105% of label claim"}
Generated Narrative: ObservationDefinition 23 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #OSh2K3VxRC96hI5W org/fhir/StructureDefinition/stability-test-type: Degradation org/fhir/StructureDefinition/stability-test-description: Purity & Impurities org/fhir/StructureDefinition/stability-test-subtype: Degs1 org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "NMT 0.2 % w/w"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Degradation (Deg1)
{"Acceptance Criteria": "NMT 0.2 % w/w"}
Generated Narrative: ObservationDefinition 24 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #ehxHeSsm1vB05Sjd org/fhir/StructureDefinition/stability-test-type: Degradation org/fhir/StructureDefinition/stability-test-description: Purity & Impurities org/fhir/StructureDefinition/stability-test-subtype: Degs2 org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "NMT 0.3 % w/w"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Degradation (Deg2)
{"Acceptance Criteria": "NMT 0.3 % w/w"}
Generated Narrative: ObservationDefinition 25 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #Viyfyij88rTTwKPj org/fhir/StructureDefinition/stability-test-type: Degradation org/fhir/StructureDefinition/stability-test-description: Purity & Impurities org/fhir/StructureDefinition/stability-test-subtype: Degs3 org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "NMT 0.3 % w/w"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Degradation (Deg3)
Generated Narrative: ObservationDefinition 26 version: 1; Last updated: 2025-06-05 21:07:12+0000; Information Source: #BGROTtkgEoRom94m org/fhir/StructureDefinition/stability-test-type: Dissolution Values org/fhir/StructureDefinition/stability-test-description: Physico-chemical properties org/fhir/StructureDefinition/stability-test-subtype: Individual org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"} org/fhir/StructureDefinition/protocol-reference: PlanDefinition/4 status: Active code: Dissolution (Individual)
Generated Narrative: ObservationDefinition 5 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #0NoTjrGkrOGwBD7o org/fhir/StructureDefinition/stability-test-type: Assay org/fhir/StructureDefinition/stability-test-description: Assay org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "95% to 105% of label claim"} status: Active code: Assay
Generated Narrative: ObservationDefinition 6 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #DDlrsWVnEH99Dnbc org/fhir/StructureDefinition/stability-test-type: Degradation org/fhir/StructureDefinition/stability-test-description: Purity & Impurities org/fhir/StructureDefinition/stability-test-subtype: Degs1 org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "NMT 0.2 % w/w"} status: Active code: Degradation (Deg1)
Generated Narrative: ObservationDefinition 7 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #TiST3CGSF436JmjQ org/fhir/StructureDefinition/stability-test-type: Degradation org/fhir/StructureDefinition/stability-test-description: Purity & Impurities org/fhir/StructureDefinition/stability-test-subtype: Degs2 org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "NMT 0.3 % w/w"} status: Active code: Degradation (Deg2)
Generated Narrative: ObservationDefinition 8 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #DePmDQutbfDd6qdS org/fhir/StructureDefinition/stability-test-type: Degradation org/fhir/StructureDefinition/stability-test-description: Purity & Impurities org/fhir/StructureDefinition/stability-test-subtype: Degs3 org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "NMT 0.3 % w/w"} status: Active code: Degradation (Deg3)
Generated Narrative: ObservationDefinition 9 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #626sh4PYsnLUcbik org/fhir/StructureDefinition/stability-test-type: Dissolution Values org/fhir/StructureDefinition/stability-test-description: Physico-chemical properties org/fhir/StructureDefinition/stability-test-subtype: Individual org/fhir/StructureDefinition/stability-test-acceptance-criteria: {"Acceptance Criteria": "Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"} status: Active code: Dissolution (Individual)
Generated Narrative: Organization 1 version: 1; Last updated: 2025-06-05 21:05:51+0000; Information Source: #58JuskxqUL064tXJ org/fhir/StructureDefinition/organization-type: sponsor org/fhir/StructureDefinition/organization-url: http://localhost:8082/fhir active: true name: self
Generated Narrative: Organization 2 version: 2; Last updated: 2025-06-05 21:11:26+0000; Information Source: #o2Qcp10tDaoBe0N9 org/fhir/StructureDefinition/organization-type: sponsor org/fhir/StructureDefinition/organization-url: http://host.docker.internal:8001 active: true name: cro