Response to Regulatory Questions (RTQ)
0.1.0 - ci-build
Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions
| Draft as of 2025-11-11 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "ctd-categories-full"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: CodeSystem ctd-categories-full</b></p><a name=\"ctd-categories-full\"> </a><a name=\"hcctd-categories-full\"> </a><p>This case-sensitive code system <code>http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full</code> defines the following codes in a Is-A hierarchy:</p><table class=\"codes\"><tr><td><b>Lvl</b></td><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td>1</td><td style=\"white-space:nowrap\">summaries<a name=\"ctd-categories-full-summaries\"> </a></td><td>CTD Summaries</td><td>Module 2 – CTD Summaries</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> summaries.quality<a name=\"ctd-categories-full-summaries.46quality\"> </a></td><td>Quality Overall Summary</td><td>2.3 Quality Overall Summary</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.quality.intro<a name=\"ctd-categories-full-summaries.46quality.46intro\"> </a></td><td>Introduction</td><td>2.3.S/P Introduction</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.quality.body<a name=\"ctd-categories-full-summaries.46quality.46body\"> </a></td><td>Body of Data</td><td>2.3.S/P Body of Data</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.quality.literature<a name=\"ctd-categories-full-summaries.46quality.46literature\"> </a></td><td>Literature References</td><td>2.3.S/P Literature References</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> summaries.nonclinical<a name=\"ctd-categories-full-summaries.46nonclinical\"> </a></td><td>Nonclinical Overview</td><td>2.4 Nonclinical Overview</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.nonclinical.pharmacology<a name=\"ctd-categories-full-summaries.46nonclinical.46pharmacology\"> </a></td><td>Pharmacology</td><td>2.4.1-2 Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.nonclinical.pk<a name=\"ctd-categories-full-summaries.46nonclinical.46pk\"> </a></td><td>Pharmacokinetics</td><td>2.4.3 Pharmacokinetics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.nonclinical.tox<a name=\"ctd-categories-full-summaries.46nonclinical.46tox\"> </a></td><td>Toxicology</td><td>2.4.4-6 Toxicology</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> summaries.clinical<a name=\"ctd-categories-full-summaries.46clinical\"> </a></td><td>Clinical Overview</td><td>2.5 Clinical Overview</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.clinical.efficacy<a name=\"ctd-categories-full-summaries.46clinical.46efficacy\"> </a></td><td>Efficacy</td><td>2.5.2 Efficacy</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.clinical.safety<a name=\"ctd-categories-full-summaries.46clinical.46safety\"> </a></td><td>Safety</td><td>2.5.3 Safety</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> summaries.clinical.brm<a name=\"ctd-categories-full-summaries.46clinical.46brm\"> </a></td><td>Benefit-Risk Assessment</td><td>2.5.4 Benefit-Risk</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> summaries.synopses<a name=\"ctd-categories-full-summaries.46synopses\"> </a></td><td>Synopses of Individual Studies</td><td>2.7 Synopses of Individual Studies</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">quality<a name=\"ctd-categories-full-quality\"> </a></td><td>Quality (CMC)</td><td>Module 3 – Quality</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> quality.drug-substance<a name=\"ctd-categories-full-quality.46drug-substance\"> </a></td><td>Drug Substance</td><td>3.2.S Drug Substance</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.general<a name=\"ctd-categories-full-quality.46drug-substance.46general\"> </a></td><td>General Information</td><td>3.2.S.1 General Information</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.general.nomenclature<a name=\"ctd-categories-full-quality.46drug-substance.46general.46nomenclature\"> </a></td><td>Nomenclature</td><td>3.2.S.1.1 Nomenclature</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.general.structure<a name=\"ctd-categories-full-quality.46drug-substance.46general.46structure\"> </a></td><td>Structure</td><td>3.2.S.1.2 Structure</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.general.properties<a name=\"ctd-categories-full-quality.46drug-substance.46general.46properties\"> </a></td><td>General Properties</td><td>3.2.S.1.3 General Properties</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture\"> </a></td><td>Manufacture</td><td>3.2.S.2 Manufacture</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture.manufacturer<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46manufacturer\"> </a></td><td>Manufacturer</td><td>3.2.S.2.1 Manufacturer</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture.description<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46description\"> </a></td><td>Description of Manufacturing Process and Process Controls</td><td>3.2.S.2.2 Description of Manufacturing Process</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture.controls<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46controls\"> </a></td><td>Control of Materials</td><td>3.2.S.2.3 Control of Materials</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture.critical-steps<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46critical-steps\"> </a></td><td>Controls of Critical Steps and Intermediates</td><td>3.2.S.2.4 Controls of Critical Steps and Intermediates</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture.validation<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46validation\"> </a></td><td>Process Validation and/or Evaluation</td><td>3.2.S.2.5 Process Validation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.manufacture.development<a name=\"ctd-categories-full-quality.46drug-substance.46manufacture.46development\"> </a></td><td>Manufacturing Process Development</td><td>3.2.S.2.6 Manufacturing Process Development</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.characterisation<a name=\"ctd-categories-full-quality.46drug-substance.46characterisation\"> </a></td><td>Characterisation</td><td>3.2.S.3 Characterisation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.characterisation.elucidation<a name=\"ctd-categories-full-quality.46drug-substance.46characterisation.46elucidation\"> </a></td><td>Elucidation of Structure and Other Characteristics</td><td>3.2.S.3.1 Elucidation of Structure</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.characterisation.impurities<a name=\"ctd-categories-full-quality.46drug-substance.46characterisation.46impurities\"> </a></td><td>Impurities</td><td>3.2.S.3.2 Impurities</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.control<a name=\"ctd-categories-full-quality.46drug-substance.46control\"> </a></td><td>Control of Drug Substance</td><td>3.2.S.4 Control of Drug Substance</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.control.specification<a name=\"ctd-categories-full-quality.46drug-substance.46control.46specification\"> </a></td><td>Specification</td><td>3.2.S.4.1 Specification</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.control.analytical<a name=\"ctd-categories-full-quality.46drug-substance.46control.46analytical\"> </a></td><td>Analytical Procedures</td><td>3.2.S.4.2 Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.control.validation<a name=\"ctd-categories-full-quality.46drug-substance.46control.46validation\"> </a></td><td>Validation of Analytical Procedures</td><td>3.2.S.4.3 Validation of Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.control.batch<a name=\"ctd-categories-full-quality.46drug-substance.46control.46batch\"> </a></td><td>Batch Analyses</td><td>3.2.S.4.4 Batch Analyses</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.control.justification<a name=\"ctd-categories-full-quality.46drug-substance.46control.46justification\"> </a></td><td>Justification of Specification</td><td>3.2.S.4.5 Justification of Specification</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.reference<a name=\"ctd-categories-full-quality.46drug-substance.46reference\"> </a></td><td>Reference Standards or Materials</td><td>3.2.S.5 Reference Standards</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.container<a name=\"ctd-categories-full-quality.46drug-substance.46container\"> </a></td><td>Container Closure System</td><td>3.2.S.6 Container Closure System</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-substance.stability<a name=\"ctd-categories-full-quality.46drug-substance.46stability\"> </a></td><td>Stability</td><td>3.2.S.7 Stability</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.stability.summary<a name=\"ctd-categories-full-quality.46drug-substance.46stability.46summary\"> </a></td><td>Stability Summary and Conclusions</td><td>3.2.S.7.1 Stability Summary</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.stability.protocol<a name=\"ctd-categories-full-quality.46drug-substance.46stability.46protocol\"> </a></td><td>Post-approval Stability Protocol and Commitment</td><td>3.2.S.7.2 Post-approval Protocol</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-substance.stability.data<a name=\"ctd-categories-full-quality.46drug-substance.46stability.46data\"> </a></td><td>Stability Data</td><td>3.2.S.7.3 Stability Data</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> quality.drug-product<a name=\"ctd-categories-full-quality.46drug-product\"> </a></td><td>Drug Product</td><td>3.2.P Drug Product</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.description<a name=\"ctd-categories-full-quality.46drug-product.46description\"> </a></td><td>Description and Composition of the Drug Product</td><td>3.2.P.1 Description and Composition</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development\"> </a></td><td>Pharmaceutical Development</td><td>3.2.P.2 Pharmaceutical Development</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development.components<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46components\"> </a></td><td>Components of the Drug Product</td><td>3.2.P.2.1 Components</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development.drug-product<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46drug-product\"> </a></td><td>Drug Product</td><td>3.2.P.2.2 Drug Product</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development.manufacturing<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46manufacturing\"> </a></td><td>Manufacturing Process Development</td><td>3.2.P.2.3 Manufacturing Process Development</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development.container<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46container\"> </a></td><td>Container Closure System</td><td>3.2.P.2.4 Container Closure System</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development.microbiological<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46microbiological\"> </a></td><td>Microbiological Attributes</td><td>3.2.P.2.5 Microbiological Attributes</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.pharmaceutical-development.compatibility<a name=\"ctd-categories-full-quality.46drug-product.46pharmaceutical-development.46compatibility\"> </a></td><td>Compatibility</td><td>3.2.P.2.6 Compatibility</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.manufacture<a name=\"ctd-categories-full-quality.46drug-product.46manufacture\"> </a></td><td>Manufacture</td><td>3.2.P.3 Manufacture</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.manufacture.manufacturer<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46manufacturer\"> </a></td><td>Manufacturer(s)</td><td>3.2.P.3.1 Manufacturer(s)</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.manufacture.batch<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46batch\"> </a></td><td>Batch Formula</td><td>3.2.P.3.2 Batch Formula</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.manufacture.process<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46process\"> </a></td><td>Description of Manufacturing Process and Process Controls</td><td>3.2.P.3.3 Description of Manufacturing Process</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.manufacture.controls<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46controls\"> </a></td><td>Controls of Critical Steps and Intermediates</td><td>3.2.P.3.4 Controls of Critical Steps</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.manufacture.validation<a name=\"ctd-categories-full-quality.46drug-product.46manufacture.46validation\"> </a></td><td>Process Validation and/or Evaluation</td><td>3.2.P.3.5 Process Validation</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.excipients<a name=\"ctd-categories-full-quality.46drug-product.46excipients\"> </a></td><td>Control of Excipients</td><td>3.2.P.4 Control of Excipients</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.excipients.specifications<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46specifications\"> </a></td><td>Specifications</td><td>3.2.P.4.1 Specifications</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.excipients.analytical<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46analytical\"> </a></td><td>Analytical Procedures</td><td>3.2.P.4.2 Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.excipients.validation<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46validation\"> </a></td><td>Validation of Analytical Procedures</td><td>3.2.P.4.3 Validation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.excipients.justification<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46justification\"> </a></td><td>Justification of Specifications</td><td>3.2.P.4.4 Justification</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.excipients.novel<a name=\"ctd-categories-full-quality.46drug-product.46excipients.46novel\"> </a></td><td>Novel Excipients</td><td>3.2.P.4.5 Novel Excipients</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.control<a name=\"ctd-categories-full-quality.46drug-product.46control\"> </a></td><td>Control of Drug Product</td><td>3.2.P.5 Control of Drug Product</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.control.specification<a name=\"ctd-categories-full-quality.46drug-product.46control.46specification\"> </a></td><td>Specification</td><td>3.2.P.5.1 Specification</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.control.analytical<a name=\"ctd-categories-full-quality.46drug-product.46control.46analytical\"> </a></td><td>Analytical Procedures</td><td>3.2.P.5.2 Analytical Procedures</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.control.validation<a name=\"ctd-categories-full-quality.46drug-product.46control.46validation\"> </a></td><td>Validation of Analytical Procedures</td><td>3.2.P.5.3 Validation</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.control.batch<a name=\"ctd-categories-full-quality.46drug-product.46control.46batch\"> </a></td><td>Batch Analyses</td><td>3.2.P.5.4 Batch Analyses</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.control.characterisation<a name=\"ctd-categories-full-quality.46drug-product.46control.46characterisation\"> </a></td><td>Characterisation of Impurities</td><td>3.2.P.5.5 Characterisation of Impurities</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.control.justification<a name=\"ctd-categories-full-quality.46drug-product.46control.46justification\"> </a></td><td>Justification of Specification</td><td>3.2.P.5.6 Justification</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.reference<a name=\"ctd-categories-full-quality.46drug-product.46reference\"> </a></td><td>Reference Standards or Materials</td><td>3.2.P.6 Reference Standards</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.container<a name=\"ctd-categories-full-quality.46drug-product.46container\"> </a></td><td>Container Closure System</td><td>3.2.P.7 Container Closure System</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.drug-product.stability<a name=\"ctd-categories-full-quality.46drug-product.46stability\"> </a></td><td>Stability</td><td>3.2.P.8 Stability</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.stability.summary<a name=\"ctd-categories-full-quality.46drug-product.46stability.46summary\"> </a></td><td>Stability Summary and Conclusions</td><td>3.2.P.8.1 Stability Summary</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.stability.protocol<a name=\"ctd-categories-full-quality.46drug-product.46stability.46protocol\"> </a></td><td>Post-approval Stability Protocol and Commitment</td><td>3.2.P.8.2 Post-approval Protocol</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> quality.drug-product.stability.data<a name=\"ctd-categories-full-quality.46drug-product.46stability.46data\"> </a></td><td>Stability Data</td><td>3.2.P.8.3 Stability Data</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> quality.appendices<a name=\"ctd-categories-full-quality.46appendices\"> </a></td><td>Appendices</td><td>3.2.A Appendices</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.appendices.facilities<a name=\"ctd-categories-full-quality.46appendices.46facilities\"> </a></td><td>Facilities and Equipment</td><td>3.2.A.1 Facilities and Equipment</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.appendices.adventitious<a name=\"ctd-categories-full-quality.46appendices.46adventitious\"> </a></td><td>Adventitious Agents Safety Evaluation</td><td>3.2.A.2 Adventitious Agents</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> quality.appendices.novel-excipients<a name=\"ctd-categories-full-quality.46appendices.46novel-excipients\"> </a></td><td>Novel Excipients</td><td>3.2.A.3 Novel Excipients</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> quality.regional<a name=\"ctd-categories-full-quality.46regional\"> </a></td><td>Regional Information</td><td>3.3 Regional Information</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">nonclinical<a name=\"ctd-categories-full-nonclinical\"> </a></td><td>Nonclinical Study Reports</td><td>Module 4 – Nonclinical Study Reports</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> nonclinical.pharmacology<a name=\"ctd-categories-full-nonclinical.46pharmacology\"> </a></td><td>Pharmacology</td><td>4.2 Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pharmacology.primary<a name=\"ctd-categories-full-nonclinical.46pharmacology.46primary\"> </a></td><td>Primary Pharmacodynamics</td><td>4.2.1.1 Primary Pharmacodynamics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pharmacology.secondary<a name=\"ctd-categories-full-nonclinical.46pharmacology.46secondary\"> </a></td><td>Secondary Pharmacodynamics</td><td>4.2.1.2 Secondary Pharmacodynamics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pharmacology.safety<a name=\"ctd-categories-full-nonclinical.46pharmacology.46safety\"> </a></td><td>Safety Pharmacology</td><td>4.2.1.3 Safety Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pharmacology.discussion<a name=\"ctd-categories-full-nonclinical.46pharmacology.46discussion\"> </a></td><td>Pharmacodynamic Drug Interactions</td><td>4.2.1.4 Pharmacodynamic Drug Interactions</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> nonclinical.pk<a name=\"ctd-categories-full-nonclinical.46pk\"> </a></td><td>Pharmacokinetics</td><td>4.2.2 Pharmacokinetics</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pk.absorption<a name=\"ctd-categories-full-nonclinical.46pk.46absorption\"> </a></td><td>Absorption</td><td>4.2.2.1 Absorption</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pk.distribution<a name=\"ctd-categories-full-nonclinical.46pk.46distribution\"> </a></td><td>Distribution</td><td>4.2.2.2 Distribution</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pk.metabolism<a name=\"ctd-categories-full-nonclinical.46pk.46metabolism\"> </a></td><td>Metabolism</td><td>4.2.2.3 Metabolism</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pk.excretion<a name=\"ctd-categories-full-nonclinical.46pk.46excretion\"> </a></td><td>Excretion</td><td>4.2.2.4 Excretion</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.pk.interactions<a name=\"ctd-categories-full-nonclinical.46pk.46interactions\"> </a></td><td>PK Drug Interactions</td><td>4.2.2.5 PK Drug Interactions</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> nonclinical.toxicology<a name=\"ctd-categories-full-nonclinical.46toxicology\"> </a></td><td>Toxicology</td><td>4.2.3 Toxicology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.single<a name=\"ctd-categories-full-nonclinical.46toxicology.46single\"> </a></td><td>Single-Dose Toxicity</td><td>4.2.3.1 Single-Dose Toxicity</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.repeat<a name=\"ctd-categories-full-nonclinical.46toxicology.46repeat\"> </a></td><td>Repeat-Dose Toxicity</td><td>4.2.3.2 Repeat-Dose Toxicity</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.geno<a name=\"ctd-categories-full-nonclinical.46toxicology.46geno\"> </a></td><td>Genotoxicity</td><td>4.2.3.3 Genotoxicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.geno.invitro<a name=\"ctd-categories-full-nonclinical.46toxicology.46geno.46invitro\"> </a></td><td>In Vitro</td><td>4.2.3.3.1 In Vitro</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.geno.invivo<a name=\"ctd-categories-full-nonclinical.46toxicology.46geno.46invivo\"> </a></td><td>In Vivo</td><td>4.2.3.3.2 In Vivo</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.carc<a name=\"ctd-categories-full-nonclinical.46toxicology.46carc\"> </a></td><td>Carcinogenicity</td><td>4.2.3.4 Carcinogenicity</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.repro<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro\"> </a></td><td>Reproductive and Developmental Toxicity</td><td>4.2.3.5 Reproductive Toxicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.repro.fertility<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro.46fertility\"> </a></td><td>Fertility and Early Embryonic Development</td><td>4.2.3.5.1 Fertility</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.repro.embryo<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro.46embryo\"> </a></td><td>Embryo-Fetal Development</td><td>4.2.3.5.2 Embryo-Fetal</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.repro.peri<a name=\"ctd-categories-full-nonclinical.46toxicology.46repro.46peri\"> </a></td><td>Peri- and Post-Natal Development</td><td>4.2.3.5.3 Peri-/Post-Natal</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.local<a name=\"ctd-categories-full-nonclinical.46toxicology.46local\"> </a></td><td>Local Tolerance</td><td>4.2.3.6 Local Tolerance</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other<a name=\"ctd-categories-full-nonclinical.46toxicology.46other\"> </a></td><td>Other Toxicity Studies</td><td>4.2.3.7 Other Toxicity Studies</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other.antigenicity<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46antigenicity\"> </a></td><td>Antigenicity</td><td>4.2.3.7.1 Antigenicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other.immunotox<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46immunotox\"> </a></td><td>Immunotoxicity</td><td>4.2.3.7.2 Immunotoxicity</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other.mechanistic<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46mechanistic\"> </a></td><td>Mechanistic Studies</td><td>4.2.3.7.3 Mechanistic</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other.impurities<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46impurities\"> </a></td><td>Impurities</td><td>4.2.3.7.4 Impurities</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other.metabolites<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46metabolites\"> </a></td><td>Metabolites</td><td>4.2.3.7.5 Metabolites</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> nonclinical.toxicology.other.other<a name=\"ctd-categories-full-nonclinical.46toxicology.46other.46other\"> </a></td><td>Other</td><td>4.2.3.7.6 Other</td></tr><tr><td>1</td><td style=\"white-space:nowrap\">clinical<a name=\"ctd-categories-full-clinical\"> </a></td><td>Clinical Study Reports</td><td>Module 5 – Clinical Study Reports</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> clinical.biopharm<a name=\"ctd-categories-full-clinical.46biopharm\"> </a></td><td>Biopharmaceutic Studies</td><td>5.2 Biopharmaceutic Studies</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.biopharm.ba-be<a name=\"ctd-categories-full-clinical.46biopharm.46ba-be\"> </a></td><td>Bioavailability / Bioequivalence</td><td>5.2.1-2 BA/BE Studies</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.biopharm.invitro<a name=\"ctd-categories-full-clinical.46biopharm.46invitro\"> </a></td><td>In Vitro–In Vivo Correlation</td><td>5.2.3 IVIVC</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> clinical.pk<a name=\"ctd-categories-full-clinical.46pk\"> </a></td><td>Clinical Pharmacology Studies</td><td>5.3 Clinical Pharmacology</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.pk.healthy<a name=\"ctd-categories-full-clinical.46pk.46healthy\"> </a></td><td>Studies in Healthy Subjects</td><td>5.3.1 Healthy Subjects</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.pk.patient<a name=\"ctd-categories-full-clinical.46pk.46patient\"> </a></td><td>Studies in Target Population</td><td>5.3.2 Target Population</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.pk.intrinsic<a name=\"ctd-categories-full-clinical.46pk.46intrinsic\"> </a></td><td>Intrinsic Factors</td><td>5.3.3 Intrinsic Factors</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> clinical.pk.intrinsic.renal<a name=\"ctd-categories-full-clinical.46pk.46intrinsic.46renal\"> </a></td><td>Renal Impairment</td><td>5.3.3.1 Renal</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> clinical.pk.intrinsic.hepatic<a name=\"ctd-categories-full-clinical.46pk.46intrinsic.46hepatic\"> </a></td><td>Hepatic Impairment</td><td>5.3.3.2 Hepatic</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> clinical.pk.intrinsic.age<a name=\"ctd-categories-full-clinical.46pk.46intrinsic.46age\"> </a></td><td>Age / Pediatric</td><td>5.3.3.3 Age/Pediatric</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.pk.extrinsic<a name=\"ctd-categories-full-clinical.46pk.46extrinsic\"> </a></td><td>Extrinsic Factors</td><td>5.3.4 Extrinsic Factors</td></tr><tr><td>4</td><td style=\"white-space:nowrap\"> clinical.pk.extrinsic.ddi<a name=\"ctd-categories-full-clinical.46pk.46extrinsic.46ddi\"> </a></td><td>Drug-Drug Interactions</td><td>5.3.4.1 DDI</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.pk.pop<a name=\"ctd-categories-full-clinical.46pk.46pop\"> </a></td><td>Population PK</td><td>5.3.5 Population PK</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> clinical.efficacy<a name=\"ctd-categories-full-clinical.46efficacy\"> </a></td><td>Clinical Efficacy & Safety Studies</td><td>5.3.5-5.4 Efficacy and Safety</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.efficacy.controlled<a name=\"ctd-categories-full-clinical.46efficacy.46controlled\"> </a></td><td>Controlled Clinical Studies</td><td>5.3.5.1 Controlled Studies</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.efficacy.uncontrolled<a name=\"ctd-categories-full-clinical.46efficacy.46uncontrolled\"> </a></td><td>Uncontrolled Studies</td><td>5.3.5.2 Uncontrolled</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.efficacy.other<a name=\"ctd-categories-full-clinical.46efficacy.46other\"> </a></td><td>Other Studies</td><td>5.3.5.3 Other</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.efficacy.analysis<a name=\"ctd-categories-full-clinical.46efficacy.46analysis\"> </a></td><td>Analyses of Efficacy</td><td>5.3.5.4 Analyses</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> clinical.safety<a name=\"ctd-categories-full-clinical.46safety\"> </a></td><td>Safety Data</td><td>5.3.6 Safety</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.safety.exposure<a name=\"ctd-categories-full-clinical.46safety.46exposure\"> </a></td><td>Extent of Exposure</td><td>5.3.6.1 Exposure</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.safety.ae<a name=\"ctd-categories-full-clinical.46safety.46ae\"> </a></td><td>Adverse Events</td><td>5.3.6.2 AEs</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.safety.lab<a name=\"ctd-categories-full-clinical.46safety.46lab\"> </a></td><td>Clinical Laboratory</td><td>5.3.6.3 Lab</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.safety.vital<a name=\"ctd-categories-full-clinical.46safety.46vital\"> </a></td><td>Vital Signs / ECG</td><td>5.3.6.4 Vital/ECG</td></tr><tr><td>3</td><td style=\"white-space:nowrap\"> clinical.safety.immuno<a name=\"ctd-categories-full-clinical.46safety.46immuno\"> </a></td><td>Immunogenicity</td><td>5.3.6.5 Immunogenicity</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> clinical.literature<a name=\"ctd-categories-full-clinical.46literature\"> </a></td><td>Literature References</td><td>5.4 Literature References</td></tr><tr><td>2</td><td style=\"white-space:nowrap\"> clinical.synopses<a name=\"ctd-categories-full-clinical.46synopses\"> </a></td><td>Synopses of Individual Studies</td><td>5.3.7 Synopses</td></tr></table></div>"^^rdf:XMLLiteral ] ] ; # fhir:url [ fhir:v "http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/src-ig/CodeSystem/ctd-categories-full> ] ; # fhir:version [ fhir:v "0.1.0"] ; # fhir:name [ fhir:v "CTDQuestionCategoriesFull"] ; # fhir:title [ fhir:v "CTD-Based Regulatory Question Categories (Full Granularity)"] ; # fhir:status [ fhir:v "draft"] ; # fhir:experimental [ fhir:v true] ; # fhir:date [ fhir:v "2025-11-11"^^xsd:date] ; # fhir:publisher [ fhir:v "HL7 International"] ; # fhir:contact ( [ fhir:name [ 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fhir:display [ fhir:v "Batch Analyses" ] ; fhir:definition [ fhir:v "3.2.S.4.4 Batch Analyses" ] ] [ fhir:code [ fhir:v "quality.drug-substance.control.justification" ] ; fhir:display [ fhir:v "Justification of Specification" ] ; fhir:definition [ fhir:v "3.2.S.4.5 Justification of Specification" ] ] ) ] [ fhir:code [ fhir:v "quality.drug-substance.reference" ] ; fhir:display [ fhir:v "Reference Standards or Materials" ] ; fhir:definition [ fhir:v "3.2.S.5 Reference Standards" ] ] [ fhir:code [ fhir:v "quality.drug-substance.container" ] ; fhir:display [ fhir:v "Container Closure System" ] ; fhir:definition [ fhir:v "3.2.S.6 Container Closure System" ] ] [ fhir:code [ fhir:v "quality.drug-substance.stability" ] ; fhir:display [ fhir:v "Stability" ] ; fhir:definition [ fhir:v "3.2.S.7 Stability" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-substance.stability.summary" ] ; fhir:display [ fhir:v "Stability Summary and Conclusions" ] ; fhir:definition [ fhir:v "3.2.S.7.1 Stability Summary" ] ] [ fhir:code [ fhir:v "quality.drug-substance.stability.protocol" ] ; fhir:display [ fhir:v "Post-approval Stability Protocol and Commitment" ] ; fhir:definition [ fhir:v "3.2.S.7.2 Post-approval Protocol" ] ] [ fhir:code [ fhir:v "quality.drug-substance.stability.data" ] ; fhir:display [ fhir:v "Stability Data" ] ; fhir:definition [ fhir:v "3.2.S.7.3 Stability Data" ] ] ) ] ) ] [ fhir:code [ fhir:v "quality.drug-product" ] ; fhir:display [ fhir:v "Drug Product" ] ; fhir:definition [ fhir:v "3.2.P Drug Product" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-product.description" ] ; fhir:display [ fhir:v "Description and Composition of the Drug Product" ] ; fhir:definition [ fhir:v "3.2.P.1 Description and Composition" ] ] [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development" ] ; fhir:display [ fhir:v "Pharmaceutical Development" ] ; fhir:definition [ fhir:v "3.2.P.2 Pharmaceutical Development" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development.components" ] ; fhir:display [ fhir:v "Components of the Drug Product" ] ; fhir:definition [ fhir:v "3.2.P.2.1 Components" ] ] [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development.drug-product" ] ; fhir:display [ fhir:v "Drug Product" ] ; fhir:definition [ fhir:v "3.2.P.2.2 Drug Product" ] ] [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development.manufacturing" ] ; fhir:display [ fhir:v "Manufacturing Process Development" ] ; fhir:definition [ fhir:v "3.2.P.2.3 Manufacturing Process Development" ] ] [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development.container" ] ; fhir:display [ fhir:v "Container Closure System" ] ; fhir:definition [ fhir:v "3.2.P.2.4 Container Closure System" ] ] [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development.microbiological" ] ; fhir:display [ fhir:v "Microbiological Attributes" ] ; fhir:definition [ fhir:v "3.2.P.2.5 Microbiological Attributes" ] ] [ fhir:code [ fhir:v "quality.drug-product.pharmaceutical-development.compatibility" ] ; fhir:display [ fhir:v "Compatibility" ] ; fhir:definition [ fhir:v "3.2.P.2.6 Compatibility" ] ] ) ] [ fhir:code [ fhir:v "quality.drug-product.manufacture" ] ; fhir:display [ fhir:v "Manufacture" ] ; fhir:definition [ fhir:v "3.2.P.3 Manufacture" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-product.manufacture.manufacturer" ] ; fhir:display [ fhir:v "Manufacturer(s)" ] ; fhir:definition [ fhir:v "3.2.P.3.1 Manufacturer(s)" ] ] [ fhir:code [ fhir:v "quality.drug-product.manufacture.batch" ] ; fhir:display [ fhir:v "Batch Formula" ] ; fhir:definition [ fhir:v "3.2.P.3.2 Batch Formula" ] ] [ fhir:code [ fhir:v "quality.drug-product.manufacture.process" ] ; fhir:display [ fhir:v "Description of Manufacturing Process and Process Controls" ] ; fhir:definition [ fhir:v "3.2.P.3.3 Description of Manufacturing Process" ] ] [ fhir:code [ fhir:v "quality.drug-product.manufacture.controls" ] ; fhir:display [ fhir:v "Controls of Critical Steps and Intermediates" ] ; fhir:definition [ fhir:v "3.2.P.3.4 Controls of Critical Steps" ] ] [ fhir:code [ fhir:v "quality.drug-product.manufacture.validation" ] ; fhir:display [ fhir:v "Process Validation and/or Evaluation" ] ; fhir:definition [ fhir:v "3.2.P.3.5 Process Validation" ] ] ) ] [ fhir:code [ fhir:v "quality.drug-product.excipients" ] ; fhir:display [ fhir:v "Control of Excipients" ] ; fhir:definition [ fhir:v "3.2.P.4 Control of Excipients" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-product.excipients.specifications" ] ; fhir:display [ fhir:v "Specifications" ] ; fhir:definition [ fhir:v "3.2.P.4.1 Specifications" ] ] [ fhir:code [ fhir:v "quality.drug-product.excipients.analytical" ] ; fhir:display [ fhir:v "Analytical Procedures" ] ; fhir:definition [ fhir:v "3.2.P.4.2 Analytical Procedures" ] ] [ fhir:code [ fhir:v "quality.drug-product.excipients.validation" ] ; fhir:display [ fhir:v "Validation of Analytical Procedures" ] ; fhir:definition [ fhir:v "3.2.P.4.3 Validation" ] ] [ fhir:code [ fhir:v "quality.drug-product.excipients.justification" ] ; fhir:display [ fhir:v "Justification of Specifications" ] ; fhir:definition [ fhir:v "3.2.P.4.4 Justification" ] ] [ fhir:code [ fhir:v "quality.drug-product.excipients.novel" ] ; fhir:display [ fhir:v "Novel Excipients" ] ; fhir:definition [ fhir:v "3.2.P.4.5 Novel Excipients" ] ] ) ] [ fhir:code [ fhir:v "quality.drug-product.control" ] ; fhir:display [ fhir:v "Control of Drug Product" ] ; fhir:definition [ fhir:v "3.2.P.5 Control of Drug Product" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-product.control.specification" ] ; fhir:display [ fhir:v "Specification" ] ; fhir:definition [ fhir:v "3.2.P.5.1 Specification" ] ] [ fhir:code [ fhir:v "quality.drug-product.control.analytical" ] ; fhir:display [ fhir:v "Analytical Procedures" ] ; fhir:definition [ fhir:v "3.2.P.5.2 Analytical Procedures" ] ] [ fhir:code [ fhir:v "quality.drug-product.control.validation" ] ; fhir:display [ fhir:v "Validation of Analytical Procedures" ] ; fhir:definition [ fhir:v "3.2.P.5.3 Validation" ] ] [ fhir:code [ fhir:v "quality.drug-product.control.batch" ] ; fhir:display [ fhir:v "Batch Analyses" ] ; fhir:definition [ fhir:v "3.2.P.5.4 Batch Analyses" ] ] [ fhir:code [ fhir:v "quality.drug-product.control.characterisation" ] ; fhir:display [ fhir:v "Characterisation of Impurities" ] ; fhir:definition [ fhir:v "3.2.P.5.5 Characterisation of Impurities" ] ] [ fhir:code [ fhir:v "quality.drug-product.control.justification" ] ; fhir:display [ fhir:v "Justification of Specification" ] ; fhir:definition [ fhir:v "3.2.P.5.6 Justification" ] ] ) ] [ fhir:code [ fhir:v "quality.drug-product.reference" ] ; fhir:display [ fhir:v "Reference Standards or Materials" ] ; fhir:definition [ fhir:v "3.2.P.6 Reference Standards" ] ] [ fhir:code [ fhir:v "quality.drug-product.container" ] ; fhir:display [ fhir:v "Container Closure System" ] ; fhir:definition [ fhir:v "3.2.P.7 Container Closure System" ] ] [ fhir:code [ fhir:v "quality.drug-product.stability" ] ; fhir:display [ fhir:v "Stability" ] ; fhir:definition [ fhir:v "3.2.P.8 Stability" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.drug-product.stability.summary" ] ; fhir:display [ fhir:v "Stability Summary and Conclusions" ] ; fhir:definition [ fhir:v "3.2.P.8.1 Stability Summary" ] ] [ fhir:code [ fhir:v "quality.drug-product.stability.protocol" ] ; fhir:display [ fhir:v "Post-approval Stability Protocol and Commitment" ] ; fhir:definition [ fhir:v "3.2.P.8.2 Post-approval Protocol" ] ] [ fhir:code [ fhir:v "quality.drug-product.stability.data" ] ; fhir:display [ fhir:v "Stability Data" ] ; fhir:definition [ fhir:v "3.2.P.8.3 Stability Data" ] ] ) ] ) ] [ fhir:code [ fhir:v "quality.appendices" ] ; fhir:display [ fhir:v "Appendices" ] ; fhir:definition [ fhir:v "3.2.A Appendices" ] ; ( fhir:concept [ fhir:code [ fhir:v "quality.appendices.facilities" ] ; fhir:display [ fhir:v "Facilities and Equipment" ] ; fhir:definition [ fhir:v "3.2.A.1 Facilities and Equipment" ] ] [ fhir:code [ fhir:v "quality.appendices.adventitious" ] ; fhir:display [ fhir:v "Adventitious Agents Safety Evaluation" ] ; fhir:definition [ fhir:v "3.2.A.2 Adventitious Agents" ] ] [ fhir:code [ fhir:v "quality.appendices.novel-excipients" ] ; fhir:display [ fhir:v "Novel Excipients" ] ; fhir:definition [ fhir:v "3.2.A.3 Novel Excipients" ] ] ) ] [ fhir:code [ fhir:v "quality.regional" ] ; fhir:display [ fhir:v "Regional Information" ] ; fhir:definition [ fhir:v "3.3 Regional Information" ] ] ) ] [ fhir:code [ fhir:v "nonclinical" ] ; fhir:display [ fhir:v "Nonclinical Study Reports" ] ; fhir:definition [ fhir:v "Module 4 – Nonclinical Study Reports" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.pharmacology" ] ; fhir:display [ fhir:v "Pharmacology" ] ; fhir:definition [ fhir:v "4.2 Pharmacology" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.pharmacology.primary" ] ; fhir:display [ fhir:v "Primary Pharmacodynamics" ] ; fhir:definition [ fhir:v "4.2.1.1 Primary Pharmacodynamics" ] ] [ fhir:code [ fhir:v "nonclinical.pharmacology.secondary" ] ; fhir:display [ fhir:v "Secondary Pharmacodynamics" ] ; fhir:definition [ fhir:v "4.2.1.2 Secondary Pharmacodynamics" ] ] [ fhir:code [ fhir:v "nonclinical.pharmacology.safety" ] ; fhir:display [ fhir:v "Safety Pharmacology" ] ; fhir:definition [ fhir:v "4.2.1.3 Safety Pharmacology" ] ] [ fhir:code [ fhir:v "nonclinical.pharmacology.discussion" ] ; fhir:display [ fhir:v "Pharmacodynamic Drug Interactions" ] ; fhir:definition [ fhir:v "4.2.1.4 Pharmacodynamic Drug Interactions" ] ] ) ] [ fhir:code [ fhir:v "nonclinical.pk" ] ; fhir:display [ fhir:v "Pharmacokinetics" ] ; fhir:definition [ fhir:v "4.2.2 Pharmacokinetics" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.pk.absorption" ] ; fhir:display [ fhir:v "Absorption" ] ; fhir:definition [ fhir:v "4.2.2.1 Absorption" ] ] [ fhir:code [ fhir:v "nonclinical.pk.distribution" ] ; fhir:display [ fhir:v "Distribution" ] ; fhir:definition [ fhir:v "4.2.2.2 Distribution" ] ] [ fhir:code [ fhir:v "nonclinical.pk.metabolism" ] ; fhir:display [ fhir:v "Metabolism" ] ; fhir:definition [ fhir:v "4.2.2.3 Metabolism" ] ] [ fhir:code [ fhir:v "nonclinical.pk.excretion" ] ; fhir:display [ fhir:v "Excretion" ] ; fhir:definition [ fhir:v "4.2.2.4 Excretion" ] ] [ fhir:code [ fhir:v "nonclinical.pk.interactions" ] ; fhir:display [ fhir:v "PK Drug Interactions" ] ; fhir:definition [ fhir:v "4.2.2.5 PK Drug Interactions" ] ] ) ] [ fhir:code [ fhir:v "nonclinical.toxicology" ] ; fhir:display [ fhir:v "Toxicology" ] ; fhir:definition [ fhir:v "4.2.3 Toxicology" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.toxicology.single" ] ; fhir:display [ fhir:v "Single-Dose Toxicity" ] ; fhir:definition [ fhir:v "4.2.3.1 Single-Dose Toxicity" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.repeat" ] ; fhir:display [ fhir:v "Repeat-Dose Toxicity" ] ; fhir:definition [ fhir:v "4.2.3.2 Repeat-Dose Toxicity" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.geno" ] ; fhir:display [ fhir:v "Genotoxicity" ] ; fhir:definition [ fhir:v "4.2.3.3 Genotoxicity" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.toxicology.geno.invitro" ] ; fhir:display [ fhir:v "In Vitro" ] ; fhir:definition [ fhir:v "4.2.3.3.1 In Vitro" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.geno.invivo" ] ; fhir:display [ fhir:v "In Vivo" ] ; fhir:definition [ fhir:v "4.2.3.3.2 In Vivo" ] ] ) ] [ fhir:code [ fhir:v "nonclinical.toxicology.carc" ] ; fhir:display [ fhir:v "Carcinogenicity" ] ; fhir:definition [ fhir:v "4.2.3.4 Carcinogenicity" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.repro" ] ; fhir:display [ fhir:v "Reproductive and Developmental Toxicity" ] ; fhir:definition [ fhir:v "4.2.3.5 Reproductive Toxicity" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.toxicology.repro.fertility" ] ; fhir:display [ fhir:v "Fertility and Early Embryonic Development" ] ; fhir:definition [ fhir:v "4.2.3.5.1 Fertility" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.repro.embryo" ] ; fhir:display [ fhir:v "Embryo-Fetal Development" ] ; fhir:definition [ fhir:v "4.2.3.5.2 Embryo-Fetal" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.repro.peri" ] ; fhir:display [ fhir:v "Peri- and Post-Natal Development" ] ; fhir:definition [ fhir:v "4.2.3.5.3 Peri-/Post-Natal" ] ] ) ] [ fhir:code [ fhir:v "nonclinical.toxicology.local" ] ; fhir:display [ fhir:v "Local Tolerance" ] ; fhir:definition [ fhir:v "4.2.3.6 Local Tolerance" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.other" ] ; fhir:display [ fhir:v "Other Toxicity Studies" ] ; fhir:definition [ fhir:v "4.2.3.7 Other Toxicity Studies" ] ; ( fhir:concept [ fhir:code [ fhir:v "nonclinical.toxicology.other.antigenicity" ] ; fhir:display [ fhir:v "Antigenicity" ] ; fhir:definition [ fhir:v "4.2.3.7.1 Antigenicity" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.other.immunotox" ] ; fhir:display [ fhir:v "Immunotoxicity" ] ; fhir:definition [ fhir:v "4.2.3.7.2 Immunotoxicity" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.other.mechanistic" ] ; fhir:display [ fhir:v "Mechanistic Studies" ] ; fhir:definition [ fhir:v "4.2.3.7.3 Mechanistic" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.other.impurities" ] ; fhir:display [ fhir:v "Impurities" ] ; fhir:definition [ fhir:v "4.2.3.7.4 Impurities" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.other.metabolites" ] ; fhir:display [ fhir:v "Metabolites" ] ; fhir:definition [ fhir:v "4.2.3.7.5 Metabolites" ] ] [ fhir:code [ fhir:v "nonclinical.toxicology.other.other" ] ; fhir:display [ fhir:v "Other" ] ; fhir:definition [ fhir:v "4.2.3.7.6 Other" ] ] ) ] ) ] ) ] [ fhir:code [ fhir:v "clinical" ] ; fhir:display [ fhir:v "Clinical Study Reports" ] ; fhir:definition [ fhir:v "Module 5 – Clinical Study Reports" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.biopharm" ] ; fhir:display [ fhir:v "Biopharmaceutic Studies" ] ; fhir:definition [ fhir:v "5.2 Biopharmaceutic Studies" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.biopharm.ba-be" ] ; fhir:display [ fhir:v "Bioavailability / Bioequivalence" ] ; fhir:definition [ fhir:v "5.2.1-2 BA/BE Studies" ] ] [ fhir:code [ fhir:v "clinical.biopharm.invitro" ] ; fhir:display [ fhir:v "In Vitro–In Vivo Correlation" ] ; fhir:definition [ fhir:v "5.2.3 IVIVC" ] ] ) ] [ fhir:code [ fhir:v "clinical.pk" ] ; fhir:display [ fhir:v "Clinical Pharmacology Studies" ] ; fhir:definition [ fhir:v "5.3 Clinical Pharmacology" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.pk.healthy" ] ; fhir:display [ fhir:v "Studies in Healthy Subjects" ] ; fhir:definition [ fhir:v "5.3.1 Healthy Subjects" ] ] [ fhir:code [ fhir:v "clinical.pk.patient" ] ; fhir:display [ fhir:v "Studies in Target Population" ] ; fhir:definition [ fhir:v "5.3.2 Target Population" ] ] [ fhir:code [ fhir:v "clinical.pk.intrinsic" ] ; fhir:display [ fhir:v "Intrinsic Factors" ] ; fhir:definition [ fhir:v "5.3.3 Intrinsic Factors" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.pk.intrinsic.renal" ] ; fhir:display [ fhir:v "Renal Impairment" ] ; fhir:definition [ fhir:v "5.3.3.1 Renal" ] ] [ fhir:code [ fhir:v "clinical.pk.intrinsic.hepatic" ] ; fhir:display [ fhir:v "Hepatic Impairment" ] ; fhir:definition [ fhir:v "5.3.3.2 Hepatic" ] ] [ fhir:code [ fhir:v "clinical.pk.intrinsic.age" ] ; fhir:display [ fhir:v "Age / Pediatric" ] ; fhir:definition [ fhir:v "5.3.3.3 Age/Pediatric" ] ] ) ] [ fhir:code [ fhir:v "clinical.pk.extrinsic" ] ; fhir:display [ fhir:v "Extrinsic Factors" ] ; fhir:definition [ fhir:v "5.3.4 Extrinsic Factors" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.pk.extrinsic.ddi" ] ; fhir:display [ fhir:v "Drug-Drug Interactions" ] ; fhir:definition [ fhir:v "5.3.4.1 DDI" ] ] ) ] [ fhir:code [ fhir:v "clinical.pk.pop" ] ; fhir:display [ fhir:v "Population PK" ] ; fhir:definition [ fhir:v "5.3.5 Population PK" ] ] ) ] [ fhir:code [ fhir:v "clinical.efficacy" ] ; fhir:display [ fhir:v "Clinical Efficacy & Safety Studies" ] ; fhir:definition [ fhir:v "5.3.5-5.4 Efficacy and Safety" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.efficacy.controlled" ] ; fhir:display [ fhir:v "Controlled Clinical Studies" ] ; fhir:definition [ fhir:v "5.3.5.1 Controlled Studies" ] ] [ fhir:code [ fhir:v "clinical.efficacy.uncontrolled" ] ; fhir:display [ fhir:v "Uncontrolled Studies" ] ; fhir:definition [ fhir:v "5.3.5.2 Uncontrolled" ] ] [ fhir:code [ fhir:v "clinical.efficacy.other" ] ; fhir:display [ fhir:v "Other Studies" ] ; fhir:definition [ fhir:v "5.3.5.3 Other" ] ] [ fhir:code [ fhir:v "clinical.efficacy.analysis" ] ; fhir:display [ fhir:v "Analyses of Efficacy" ] ; fhir:definition [ fhir:v "5.3.5.4 Analyses" ] ] ) ] [ fhir:code [ fhir:v "clinical.safety" ] ; fhir:display [ fhir:v "Safety Data" ] ; fhir:definition [ fhir:v "5.3.6 Safety" ] ; ( fhir:concept [ fhir:code [ fhir:v "clinical.safety.exposure" ] ; fhir:display [ fhir:v "Extent of Exposure" ] ; fhir:definition [ fhir:v "5.3.6.1 Exposure" ] ] [ fhir:code [ fhir:v "clinical.safety.ae" ] ; fhir:display [ fhir:v "Adverse Events" ] ; fhir:definition [ fhir:v "5.3.6.2 AEs" ] ] [ fhir:code [ fhir:v "clinical.safety.lab" ] ; fhir:display [ fhir:v "Clinical Laboratory" ] ; fhir:definition [ fhir:v "5.3.6.3 Lab" ] ] [ fhir:code [ fhir:v "clinical.safety.vital" ] ; fhir:display [ fhir:v "Vital Signs / ECG" ] ; fhir:definition [ fhir:v "5.3.6.4 Vital/ECG" ] ] [ fhir:code [ fhir:v "clinical.safety.immuno" ] ; fhir:display [ fhir:v "Immunogenicity" ] ; fhir:definition [ fhir:v "5.3.6.5 Immunogenicity" ] ] ) ] [ fhir:code [ fhir:v "clinical.literature" ] ; fhir:display [ fhir:v "Literature References" ] ; fhir:definition [ fhir:v "5.4 Literature References" ] ] [ fhir:code [ fhir:v "clinical.synopses" ] ; fhir:display [ fhir:v "Synopses of Individual Studies" ] ; fhir:definition [ fhir:v "5.3.7 Synopses" ] ] ) ] ) . #
IG © 2025+ HL7 International. Package hl7.fhir.uv.rtq-ig#0.1.0 based on FHIR 5.0.0. Generated 2025-11-15
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