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 |
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<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>
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<concept>
<code value="quality.drug-product.control.validation"/>
<display value="Validation of Analytical Procedures"/>
<definition value="3.2.P.5.3 Validation"/>
</concept>
<concept>
<code value="quality.drug-product.control.batch"/>
<display value="Batch Analyses"/>
<definition value="3.2.P.5.4 Batch Analyses"/>
</concept>
<concept>
<code value="quality.drug-product.control.characterisation"/>
<display value="Characterisation of Impurities"/>
<definition value="3.2.P.5.5 Characterisation of Impurities"/>
</concept>
<concept>
<code value="quality.drug-product.control.justification"/>
<display value="Justification of Specification"/>
<definition value="3.2.P.5.6 Justification"/>
</concept>
</concept>
<concept>
<code value="quality.drug-product.reference"/>
<display value="Reference Standards or Materials"/>
<definition value="3.2.P.6 Reference Standards"/>
</concept>
<concept>
<code value="quality.drug-product.container"/>
<display value="Container Closure System"/>
<definition value="3.2.P.7 Container Closure System"/>
</concept>
<concept>
<code value="quality.drug-product.stability"/>
<display value="Stability"/>
<definition value="3.2.P.8 Stability"/>
<concept>
<code value="quality.drug-product.stability.summary"/>
<display value="Stability Summary and Conclusions"/>
<definition value="3.2.P.8.1 Stability Summary"/>
</concept>
<concept>
<code value="quality.drug-product.stability.protocol"/>
<display value="Post-approval Stability Protocol and Commitment"/>
<definition value="3.2.P.8.2 Post-approval Protocol"/>
</concept>
<concept>
<code value="quality.drug-product.stability.data"/>
<display value="Stability Data"/>
<definition value="3.2.P.8.3 Stability Data"/>
</concept>
</concept>
</concept>
<concept>
<code value="quality.appendices"/>
<display value="Appendices"/>
<definition value="3.2.A Appendices"/>
<concept>
<code value="quality.appendices.facilities"/>
<display value="Facilities and Equipment"/>
<definition value="3.2.A.1 Facilities and Equipment"/>
</concept>
<concept>
<code value="quality.appendices.adventitious"/>
<display value="Adventitious Agents Safety Evaluation"/>
<definition value="3.2.A.2 Adventitious Agents"/>
</concept>
<concept>
<code value="quality.appendices.novel-excipients"/>
<display value="Novel Excipients"/>
<definition value="3.2.A.3 Novel Excipients"/>
</concept>
</concept>
<concept>
<code value="quality.regional"/>
<display value="Regional Information"/>
<definition value="3.3 Regional Information"/>
</concept>
</concept>
<concept>
<code value="nonclinical"/>
<display value="Nonclinical Study Reports"/>
<definition value="Module 4 – Nonclinical Study Reports"/>
<concept>
<code value="nonclinical.pharmacology"/>
<display value="Pharmacology"/>
<definition value="4.2 Pharmacology"/>
<concept>
<code value="nonclinical.pharmacology.primary"/>
<display value="Primary Pharmacodynamics"/>
<definition value="4.2.1.1 Primary Pharmacodynamics"/>
</concept>
<concept>
<code value="nonclinical.pharmacology.secondary"/>
<display value="Secondary Pharmacodynamics"/>
<definition value="4.2.1.2 Secondary Pharmacodynamics"/>
</concept>
<concept>
<code value="nonclinical.pharmacology.safety"/>
<display value="Safety Pharmacology"/>
<definition value="4.2.1.3 Safety Pharmacology"/>
</concept>
<concept>
<code value="nonclinical.pharmacology.discussion"/>
<display value="Pharmacodynamic Drug Interactions"/>
<definition value="4.2.1.4 Pharmacodynamic Drug Interactions"/>
</concept>
</concept>
<concept>
<code value="nonclinical.pk"/>
<display value="Pharmacokinetics"/>
<definition value="4.2.2 Pharmacokinetics"/>
<concept>
<code value="nonclinical.pk.absorption"/>
<display value="Absorption"/>
<definition value="4.2.2.1 Absorption"/>
</concept>
<concept>
<code value="nonclinical.pk.distribution"/>
<display value="Distribution"/>
<definition value="4.2.2.2 Distribution"/>
</concept>
<concept>
<code value="nonclinical.pk.metabolism"/>
<display value="Metabolism"/>
<definition value="4.2.2.3 Metabolism"/>
</concept>
<concept>
<code value="nonclinical.pk.excretion"/>
<display value="Excretion"/>
<definition value="4.2.2.4 Excretion"/>
</concept>
<concept>
<code value="nonclinical.pk.interactions"/>
<display value="PK Drug Interactions"/>
<definition value="4.2.2.5 PK Drug Interactions"/>
</concept>
</concept>
<concept>
<code value="nonclinical.toxicology"/>
<display value="Toxicology"/>
<definition value="4.2.3 Toxicology"/>
<concept>
<code value="nonclinical.toxicology.single"/>
<display value="Single-Dose Toxicity"/>
<definition value="4.2.3.1 Single-Dose Toxicity"/>
</concept>
<concept>
<code value="nonclinical.toxicology.repeat"/>
<display value="Repeat-Dose Toxicity"/>
<definition value="4.2.3.2 Repeat-Dose Toxicity"/>
</concept>
<concept>
<code value="nonclinical.toxicology.geno"/>
<display value="Genotoxicity"/>
<definition value="4.2.3.3 Genotoxicity"/>
<concept>
<code value="nonclinical.toxicology.geno.invitro"/>
<display value="In Vitro"/>
<definition value="4.2.3.3.1 In Vitro"/>
</concept>
<concept>
<code value="nonclinical.toxicology.geno.invivo"/>
<display value="In Vivo"/>
<definition value="4.2.3.3.2 In Vivo"/>
</concept>
</concept>
<concept>
<code value="nonclinical.toxicology.carc"/>
<display value="Carcinogenicity"/>
<definition value="4.2.3.4 Carcinogenicity"/>
</concept>
<concept>
<code value="nonclinical.toxicology.repro"/>
<display value="Reproductive and Developmental Toxicity"/>
<definition value="4.2.3.5 Reproductive Toxicity"/>
<concept>
<code value="nonclinical.toxicology.repro.fertility"/>
<display value="Fertility and Early Embryonic Development"/>
<definition value="4.2.3.5.1 Fertility"/>
</concept>
<concept>
<code value="nonclinical.toxicology.repro.embryo"/>
<display value="Embryo-Fetal Development"/>
<definition value="4.2.3.5.2 Embryo-Fetal"/>
</concept>
<concept>
<code value="nonclinical.toxicology.repro.peri"/>
<display value="Peri- and Post-Natal Development"/>
<definition value="4.2.3.5.3 Peri-/Post-Natal"/>
</concept>
</concept>
<concept>
<code value="nonclinical.toxicology.local"/>
<display value="Local Tolerance"/>
<definition value="4.2.3.6 Local Tolerance"/>
</concept>
<concept>
<code value="nonclinical.toxicology.other"/>
<display value="Other Toxicity Studies"/>
<definition value="4.2.3.7 Other Toxicity Studies"/>
<concept>
<code value="nonclinical.toxicology.other.antigenicity"/>
<display value="Antigenicity"/>
<definition value="4.2.3.7.1 Antigenicity"/>
</concept>
<concept>
<code value="nonclinical.toxicology.other.immunotox"/>
<display value="Immunotoxicity"/>
<definition value="4.2.3.7.2 Immunotoxicity"/>
</concept>
<concept>
<code value="nonclinical.toxicology.other.mechanistic"/>
<display value="Mechanistic Studies"/>
<definition value="4.2.3.7.3 Mechanistic"/>
</concept>
<concept>
<code value="nonclinical.toxicology.other.impurities"/>
<display value="Impurities"/>
<definition value="4.2.3.7.4 Impurities"/>
</concept>
<concept>
<code value="nonclinical.toxicology.other.metabolites"/>
<display value="Metabolites"/>
<definition value="4.2.3.7.5 Metabolites"/>
</concept>
<concept>
<code value="nonclinical.toxicology.other.other"/>
<display value="Other"/>
<definition value="4.2.3.7.6 Other"/>
</concept>
</concept>
</concept>
</concept>
<concept>
<code value="clinical"/>
<display value="Clinical Study Reports"/>
<definition value="Module 5 – Clinical Study Reports"/>
<concept>
<code value="clinical.biopharm"/>
<display value="Biopharmaceutic Studies"/>
<definition value="5.2 Biopharmaceutic Studies"/>
<concept>
<code value="clinical.biopharm.ba-be"/>
<display value="Bioavailability / Bioequivalence"/>
<definition value="5.2.1-2 BA/BE Studies"/>
</concept>
<concept>
<code value="clinical.biopharm.invitro"/>
<display value="In Vitro–In Vivo Correlation"/>
<definition value="5.2.3 IVIVC"/>
</concept>
</concept>
<concept>
<code value="clinical.pk"/>
<display value="Clinical Pharmacology Studies"/>
<definition value="5.3 Clinical Pharmacology"/>
<concept>
<code value="clinical.pk.healthy"/>
<display value="Studies in Healthy Subjects"/>
<definition value="5.3.1 Healthy Subjects"/>
</concept>
<concept>
<code value="clinical.pk.patient"/>
<display value="Studies in Target Population"/>
<definition value="5.3.2 Target Population"/>
</concept>
<concept>
<code value="clinical.pk.intrinsic"/>
<display value="Intrinsic Factors"/>
<definition value="5.3.3 Intrinsic Factors"/>
<concept>
<code value="clinical.pk.intrinsic.renal"/>
<display value="Renal Impairment"/>
<definition value="5.3.3.1 Renal"/>
</concept>
<concept>
<code value="clinical.pk.intrinsic.hepatic"/>
<display value="Hepatic Impairment"/>
<definition value="5.3.3.2 Hepatic"/>
</concept>
<concept>
<code value="clinical.pk.intrinsic.age"/>
<display value="Age / Pediatric"/>
<definition value="5.3.3.3 Age/Pediatric"/>
</concept>
</concept>
<concept>
<code value="clinical.pk.extrinsic"/>
<display value="Extrinsic Factors"/>
<definition value="5.3.4 Extrinsic Factors"/>
<concept>
<code value="clinical.pk.extrinsic.ddi"/>
<display value="Drug-Drug Interactions"/>
<definition value="5.3.4.1 DDI"/>
</concept>
</concept>
<concept>
<code value="clinical.pk.pop"/>
<display value="Population PK"/>
<definition value="5.3.5 Population PK"/>
</concept>
</concept>
<concept>
<code value="clinical.efficacy"/>
<display value="Clinical Efficacy & Safety Studies"/>
<definition value="5.3.5-5.4 Efficacy and Safety"/>
<concept>
<code value="clinical.efficacy.controlled"/>
<display value="Controlled Clinical Studies"/>
<definition value="5.3.5.1 Controlled Studies"/>
</concept>
<concept>
<code value="clinical.efficacy.uncontrolled"/>
<display value="Uncontrolled Studies"/>
<definition value="5.3.5.2 Uncontrolled"/>
</concept>
<concept>
<code value="clinical.efficacy.other"/>
<display value="Other Studies"/>
<definition value="5.3.5.3 Other"/>
</concept>
<concept>
<code value="clinical.efficacy.analysis"/>
<display value="Analyses of Efficacy"/>
<definition value="5.3.5.4 Analyses"/>
</concept>
</concept>
<concept>
<code value="clinical.safety"/>
<display value="Safety Data"/>
<definition value="5.3.6 Safety"/>
<concept>
<code value="clinical.safety.exposure"/>
<display value="Extent of Exposure"/>
<definition value="5.3.6.1 Exposure"/>
</concept>
<concept>
<code value="clinical.safety.ae"/>
<display value="Adverse Events"/>
<definition value="5.3.6.2 AEs"/>
</concept>
<concept>
<code value="clinical.safety.lab"/>
<display value="Clinical Laboratory"/>
<definition value="5.3.6.3 Lab"/>
</concept>
<concept>
<code value="clinical.safety.vital"/>
<display value="Vital Signs / ECG"/>
<definition value="5.3.6.4 Vital/ECG"/>
</concept>
<concept>
<code value="clinical.safety.immuno"/>
<display value="Immunogenicity"/>
<definition value="5.3.6.5 Immunogenicity"/>
</concept>
</concept>
<concept>
<code value="clinical.literature"/>
<display value="Literature References"/>
<definition value="5.4 Literature References"/>
</concept>
<concept>
<code value="clinical.synopses"/>
<display value="Synopses of Individual Studies"/>
<definition value="5.3.7 Synopses"/>
</concept>
</concept>
</CodeSystem>