See "Electronic Common Technical Document (eCTD) for Pharmaceuticals."
<?xml version='1.0' encoding='UTF-8' ?> <!-- From http://www.aboutctd.com/downloads/ich-ectd-3-0.dtd --> <!-- Changes prior to Version 1.00 captured in file "Historical Changes.txt ICH eCTD DTD Version 1.0 - March 6, 2002 Version 3.0 - Sept 11, 2002 Version 3.0 - Oct 1, 2002 vERSION 3.0 - Oct 8, 2002 Removed <!--Generated by XML Authority--> Changed m2-6-nonclinical-written-and-tabulated-summary to ...-summaries Changed m2-7-1-summary-of-biopharmaceutic... to ...-studies-... Changed m2-7-5-references to m2-7-5-literature-references Moved m4-2-4 and m4-2-5 under m4-2-3 (6-7) and renumbered sub-elements Made m3-2-a-1 and m3-2-a-2 repeatable (manufacturer, substance, dosageform, product-name Added attribute "manufacturer" to m3-2-p Changed m3-2-a-3-novel-excipients to m3-2-a-3-excipients Changed version attribute to "3.0" Removed the following elements 10/1/2002 m3-2-p-2-1-components-of-the-drug-product? , m3-2-p-2-2-drug-product? , m3-2-p-2-3-manufacturing-process-development? , m3-2-p-2-4-container-closure-system? , m3-2-p-2-5-microbiological-attributes? , m3-2-p-2-6-compatibility <!ELEMENT m3-2-p-2-1-components-of-the-drug-product ((leaf | node-extension)?)> <!ATTLIST m3-2-p-2-1-components-of-the-drug-product %att; > <!ELEMENT m3-2-p-2-2-drug-product ((leaf | node-extension)*)> <!ATTLIST m3-2-p-2-2-drug-product %att; > <!ELEMENT m3-2-p-2-3-manufacturing-process-development ((leaf | node-extension)*)> <!ATTLIST m3-2-p-2-3-manufacturing-process-development %att; > <!ELEMENT m3-2-p-2-4-container-closure-system ((leaf | node-extension)*)> <!ATTLIST m3-2-p-2-4-container-closure-system %att; > <!ELEMENT m3-2-p-2-5-microbiological-attributes ((leaf | node-extension)*)> <!ATTLIST m3-2-p-2-5-microbiological-attributes %att; > <!ELEMENT m3-2-p-2-6-compatibility ((leaf | node-extension)*)> <!ATTLIST m3-2-p-2-6-compatibility %att; > End of removed elements --> <!ENTITY % att " ID ID #IMPLIED xml:lang CDATA #IMPLIED"> <!-- ============================================================= --> <!-- Top-level element --> <!-- ============================================================= --> <!ELEMENT ectd:ectd (m1-administrative-information-and-prescribing-information? , m2-common-technical-document-summaries? , m3-quality? , m4-nonclinical-study-reports? , m5-clinical-study-reports?)> <!ATTLIST ectd:ectd xmlns:ectd CDATA #FIXED 'http://www.ich.org/ectd' xmlns:xlink CDATA #FIXED 'http://www.w3c.org/1999/xlink' xml:lang CDATA #IMPLIED dtd-version CDATA #FIXED '3.00' > <!-- ============================================================= --> <!-- Leaf content --> <!-- ============================================================= --> <!ELEMENT leaf (title , link-text?)> <!ATTLIST leaf ID ID #IMPLIED application-version CDATA #IMPLIED version CDATA #IMPLIED font-library CDATA #IMPLIED operation (new | append | replace | delete ) #REQUIRED modified-file CDATA #IMPLIED checksum CDATA #REQUIRED checksum-type CDATA #REQUIRED keywords CDATA #IMPLIED xmlns:xlink CDATA #FIXED 'http://www.w3c.org/1999/xlink' xlink:type CDATA #FIXED 'simple' xlink:role CDATA #IMPLIED xlink:href CDATA #IMPLIED xlink:show (new | replace | embed | other | none ) #IMPLIED xlink:actuate (onLoad | onRequest | other | none ) #IMPLIED xml:lang CDATA #IMPLIED > <!ELEMENT title (#PCDATA)> <!ATTLIST title ID ID #IMPLIED > <!ELEMENT link-text (#PCDATA | xref)*> <!ATTLIST link-text ID ID #IMPLIED > <!ELEMENT xref EMPTY> <!ATTLIST xref ID ID #IMPLIED xmlns:xlink CDATA #FIXED 'http://www.w3c.org/1999/xlink' xlink:type CDATA #FIXED 'simple' xlink:role CDATA #IMPLIED xlink:title CDATA #REQUIRED xlink:href CDATA #REQUIRED xlink:show (new | replace | embed | other | none ) #IMPLIED xlink:actuate (onLoad | onRequest | other | none ) #IMPLIED > <!ELEMENT node-extension (title , (leaf | node-extension)+)> <!ATTLIST node-extension ID ID #IMPLIED xml:lang CDATA #IMPLIED > <!-- ============================================================= --> <!-- CTD Backbone structures --> <!-- ============================================================= --> <!ELEMENT m1-administrative-information-and-prescribing-information (leaf*)> <!ATTLIST m1-administrative-information-and-prescribing-information %att; > <!ELEMENT m2-common-technical-document-summaries (leaf* , m2-2-introduction? , m2-3-quality-overall-summary? , m2-4-nonclinical-overview? , m2-5-clinical-overview? , m2-6-nonclinical-written-and-tabulated-summaries? , m2-7-clinical-summary?)> <!ATTLIST m2-common-technical-document-summaries %att; > <!ELEMENT m2-2-introduction ((leaf | node-extension)*)> <!ATTLIST m2-2-introduction %att; > <!ELEMENT m2-3-quality-overall-summary (leaf* , m2-3-introduction? , m2-3-s-drug-substance* , m2-3-p-drug-product* , m2-3-a-appendices? , m2-3-r-regional-information?)> <!ATTLIST m2-3-quality-overall-summary %att; > <!ELEMENT m2-3-introduction ((leaf | node-extension)*)> <!ATTLIST m2-3-introduction %att; > <!ELEMENT m2-3-s-drug-substance ((leaf | node-extension)*)> <!ATTLIST m2-3-s-drug-substance %att; substance CDATA #REQUIRED manufacturer CDATA #REQUIRED > <!ELEMENT m2-3-p-drug-product ((leaf | node-extension)*)> <!ATTLIST m2-3-p-drug-product %att; product-name CDATA #IMPLIED dosageform CDATA #IMPLIED manufacturer CDATA #IMPLIED > <!ELEMENT m2-3-a-appendices ((leaf | node-extension)*)> <!ATTLIST m2-3-a-appendices %att; > <!ELEMENT m2-3-r-regional-information ((leaf | node-extension)*)> <!ATTLIST m2-3-r-regional-information %att; > <!ELEMENT m2-4-nonclinical-overview ((leaf | node-extension)*)> <!ATTLIST m2-4-nonclinical-overview %att; > <!ELEMENT m2-5-clinical-overview ((leaf | node-extension)*)> <!ATTLIST m2-5-clinical-overview %att; > <!ELEMENT m2-6-nonclinical-written-and-tabulated-summaries (leaf* , m2-6-1-introduction? , m2-6-2-pharmacology-written-summary? , m2-6-3-pharmacology-tabulated-summary? , m2-6-4-pharmacokinetics-written-summary? , m2-6-5-pharmacokinetics-tabulated-summary? , m2-6-6-toxicology-written-summary? , m2-6-7-toxicology-tabulated-summary?)> <!ATTLIST m2-6-nonclinical-written-and-tabulated-summaries %att; > <!ELEMENT m2-6-1-introduction ((leaf | node-extension)*)> <!ATTLIST m2-6-1-introduction %att; > <!ELEMENT m2-6-2-pharmacology-written-summary ((leaf | node-extension)*)> <!ATTLIST m2-6-2-pharmacology-written-summary %att; > <!ELEMENT m2-6-3-pharmacology-tabulated-summary ((leaf | node-extension)*)> <!ATTLIST m2-6-3-pharmacology-tabulated-summary %att; > <!ELEMENT m2-6-4-pharmacokinetics-written-summary ((leaf | node-extension)*)> <!ATTLIST m2-6-4-pharmacokinetics-written-summary %att; > <!ELEMENT m2-6-5-pharmacokinetics-tabulated-summary ((leaf | node-extension)*)> <!ATTLIST m2-6-5-pharmacokinetics-tabulated-summary %att; > <!ELEMENT m2-6-6-toxicology-written-summary ((leaf | node-extension)*)> <!ATTLIST m2-6-6-toxicology-written-summary %att; > <!ELEMENT m2-6-7-toxicology-tabulated-summary ((leaf | node-extension)*)> <!ATTLIST m2-6-7-toxicology-tabulated-summary %att; > <!ELEMENT m2-7-clinical-summary (leaf* , m2-7-1-summary-of-biopharmaceutic-studies-and-associated-analytical-methods? , m2-7-2-summary-of-clinical-pharmacology-studies? , m2-7-3-summary-of-clinical-efficacy* , m2-7-4-summary-of-clinical-safety? , m2-7-5-literature-references? , m2-7-6-synopses-of-individual-studies?)> <!ATTLIST m2-7-clinical-summary %att; > <!ELEMENT m2-7-1-summary-of-biopharmaceutic-studies-and-associated-analytical-methods ((leaf | node-extension)*)> <!ATTLIST m2-7-1-summary-of-biopharmaceutic-studies-and-associated-analytical-methods %att; > <!ELEMENT m2-7-2-summary-of-clinical-pharmacology-studies ((leaf | node-extension)*)> <!ATTLIST m2-7-2-summary-of-clinical-pharmacology-studies %att; > <!ELEMENT m2-7-3-summary-of-clinical-efficacy ((leaf | node-extension)*)> <!ATTLIST m2-7-3-summary-of-clinical-efficacy %att; indication CDATA #IMPLIED > <!ELEMENT m2-7-4-summary-of-clinical-safety ((leaf | node-extension)*)> <!ATTLIST m2-7-4-summary-of-clinical-safety %att; > <!ELEMENT m2-7-5-literature-references ((leaf | node-extension)*)> <!ATTLIST m2-7-5-literature-references %att; > <!ELEMENT m2-7-6-synopses-of-individual-studies ((leaf | node-extension)*)> <!ATTLIST m2-7-6-synopses-of-individual-studies %att; > <!ELEMENT m3-quality (leaf* , m3-2-body-of-data? , m3-3-literature-references?)> <!ATTLIST m3-quality %att; > <!ELEMENT m3-2-body-of-data (leaf* , m3-2-s-drug-substance* , m3-2-p-drug-product* , m3-2-a-appendices? , m3-2-r-regional-information?)> <!ATTLIST m3-2-body-of-data %att; > <!ELEMENT m3-2-s-drug-substance (leaf* , m3-2-s-1-general-information? , m3-2-s-2-manufacture? , m3-2-s-3-characterisation? , m3-2-s-4-control-of-drug-substance? , m3-2-s-5-reference-standards-or-materials? , m3-2-s-6-container-closure-system? , m3-2-s-7-stability?)> <!ATTLIST m3-2-s-drug-substance %att; substance CDATA #REQUIRED manufacturer CDATA #REQUIRED > <!ELEMENT m3-2-s-1-general-information (leaf* , m3-2-s-1-1-nomenclature? , m3-2-s-1-2-structure? , m3-2-s-1-3-general-properties?)> <!ATTLIST m3-2-s-1-general-information %att; > <!ELEMENT m3-2-s-1-1-nomenclature ((leaf | node-extension)*)> <!ATTLIST m3-2-s-1-1-nomenclature %att; > <!ELEMENT m3-2-s-1-2-structure ((leaf | node-extension)*)> <!ATTLIST m3-2-s-1-2-structure %att; > <!ELEMENT m3-2-s-1-3-general-properties ((leaf | node-extension)*)> <!ATTLIST m3-2-s-1-3-general-properties %att; > <!ELEMENT m3-2-s-2-manufacture (leaf* , m3-2-s-2-1-manufacturer? , m3-2-s-2-2-description-of-manufacturing-process-and-process-controls? , m3-2-s-2-3-control-of-materials? , m3-2-s-2-4-controls-of-critical-steps-and-intermediates? , m3-2-s-2-5-process-validation-and-or-evaluation? , m3-2-s-2-6-manufacturing-process-development?)> <!ATTLIST m3-2-s-2-manufacture %att; > <!ELEMENT m3-2-s-2-1-manufacturer ((leaf | node-extension)*)> <!ATTLIST m3-2-s-2-1-manufacturer %att; > <!ELEMENT m3-2-s-2-2-description-of-manufacturing-process-and-process-controls ((leaf | node-extension)*)> <!ATTLIST m3-2-s-2-2-description-of-manufacturing-process-and-process-controls %att; > <!ELEMENT m3-2-s-2-3-control-of-materials ((leaf | node-extension)*)> <!ATTLIST m3-2-s-2-3-control-of-materials %att; > <!ELEMENT m3-2-s-2-4-controls-of-critical-steps-and-intermediates ((leaf | node-extension)*)> <!ATTLIST m3-2-s-2-4-controls-of-critical-steps-and-intermediates %att; > <!ELEMENT m3-2-s-2-5-process-validation-and-or-evaluation ((leaf | node-extension)*)> <!ATTLIST m3-2-s-2-5-process-validation-and-or-evaluation %att; > <!ELEMENT m3-2-s-2-6-manufacturing-process-development ((leaf | node-extension)*)> <!ATTLIST m3-2-s-2-6-manufacturing-process-development %att; > <!ELEMENT m3-2-s-3-characterisation (leaf* , m3-2-s-3-1-elucidation-of-structure-and-other-characteristics? , m3-2-s-3-2-impurities?)> <!ATTLIST m3-2-s-3-characterisation %att; > <!ELEMENT m3-2-s-3-1-elucidation-of-structure-and-other-characteristics ((leaf | node-extension)*)> <!ATTLIST m3-2-s-3-1-elucidation-of-structure-and-other-characteristics %att; > <!ELEMENT m3-2-s-3-2-impurities ((leaf | node-extension)*)> <!ATTLIST m3-2-s-3-2-impurities %att; > <!ELEMENT m3-2-s-4-control-of-drug-substance (leaf* , m3-2-s-4-1-specification? , m3-2-s-4-2-analytical-procedures? , m3-2-s-4-3-validation-of-analytical-procedures? , m3-2-s-4-4-batch-analyses? , m3-2-s-4-5-justification-of-specification?)> <!ATTLIST m3-2-s-4-control-of-drug-substance %att; > <!ELEMENT m3-2-s-4-1-specification ((leaf | node-extension)*)> <!ATTLIST m3-2-s-4-1-specification %att; > <!ELEMENT m3-2-s-4-2-analytical-procedures ((leaf | node-extension)*)> <!ATTLIST m3-2-s-4-2-analytical-procedures %att; > <!ELEMENT m3-2-s-4-3-validation-of-analytical-procedures ((leaf | node-extension)*)> <!ATTLIST m3-2-s-4-3-validation-of-analytical-procedures %att; > <!ELEMENT m3-2-s-4-4-batch-analyses ((leaf | node-extension)*)> <!ATTLIST m3-2-s-4-4-batch-analyses %att; > <!ELEMENT m3-2-s-4-5-justification-of-specification ((leaf | node-extension)*)> <!ATTLIST m3-2-s-4-5-justification-of-specification %att; > <!ELEMENT m3-2-s-5-reference-standards-or-materials ((leaf | node-extension)*)> <!ATTLIST m3-2-s-5-reference-standards-or-materials %att; > <!ELEMENT m3-2-s-6-container-closure-system ((leaf | node-extension)*)> <!ATTLIST m3-2-s-6-container-closure-system %att; > <!ELEMENT m3-2-s-7-stability (leaf* , m3-2-s-7-1-stability-summary-and-conclusions? , m3-2-s-7-2-post-approval-stability-protocol-and-stability-commitment? , m3-2-s-7-3-stability-data?)> <!ATTLIST m3-2-s-7-stability %att; > <!ELEMENT m3-2-s-7-1-stability-summary-and-conclusions ((leaf | node-extension)*)> <!ATTLIST m3-2-s-7-1-stability-summary-and-conclusions %att; > <!ELEMENT m3-2-s-7-2-post-approval-stability-protocol-and-stability-commitment ((leaf | node-extension)*)> <!ATTLIST m3-2-s-7-2-post-approval-stability-protocol-and-stability-commitment %att; > <!ELEMENT m3-2-s-7-3-stability-data ((leaf | node-extension)*)> <!ATTLIST m3-2-s-7-3-stability-data %att; > <!ELEMENT m3-2-p-drug-product (leaf* , m3-2-p-1-description-and-composition-of-the-drug-product? , m3-2-p-2-pharmaceutical-development? , m3-2-p-3-manufacture? , m3-2-p-4-control-of-excipients* , m3-2-p-5-control-of-drug-product? , m3-2-p-6-reference-standards-or-materials? , m3-2-p-7-container-closure-system? , m3-2-p-8-stability?)> <!ATTLIST m3-2-p-drug-product %att; product-name CDATA #IMPLIED dosageform CDATA #IMPLIED manufacturer CDATA #IMPLIED > <!ELEMENT m3-2-p-1-description-and-composition-of-the-drug-product ((leaf | node-extension)*)> <!ATTLIST m3-2-p-1-description-and-composition-of-the-drug-product %att; > <!ELEMENT m3-2-p-2-pharmaceutical-development ((leaf | node-extension)*)> <!ATTLIST m3-2-p-2-pharmaceutical-development %att; > <!ELEMENT m3-2-p-3-manufacture (leaf* , m3-2-p-3-1-manufacturers? , m3-2-p-3-2-batch-formula? , m3-2-p-3-3-description-of-manufacturing-process-and-process-controls? , m3-2-p-3-4-controls-of-critical-steps-and-intermediates? , m3-2-p-3-5-process-validation-and-or-evaluation?)> <!ATTLIST m3-2-p-3-manufacture %att; > <!ELEMENT m3-2-p-3-1-manufacturers ((leaf | node-extension)*)> <!ATTLIST m3-2-p-3-1-manufacturers %att; > <!ELEMENT m3-2-p-3-2-batch-formula ((leaf | node-extension)*)> <!ATTLIST m3-2-p-3-2-batch-formula %att; > <!ELEMENT m3-2-p-3-3-description-of-manufacturing-process-and-process-controls ((leaf | node-extension)*)> <!ATTLIST m3-2-p-3-3-description-of-manufacturing-process-and-process-controls %att; > <!ELEMENT m3-2-p-3-4-controls-of-critical-steps-and-intermediates ((leaf | node-extension)*)> <!ATTLIST m3-2-p-3-4-controls-of-critical-steps-and-intermediates %att; > <!ELEMENT m3-2-p-3-5-process-validation-and-or-evaluation ((leaf | node-extension)*)> <!ATTLIST m3-2-p-3-5-process-validation-and-or-evaluation %att; > <!ELEMENT m3-2-p-4-control-of-excipients (leaf* , m3-2-p-4-1-specifications? , m3-2-p-4-2-analytical-procedures? , m3-2-p-4-3-validation-of-analytical-procedures? , m3-2-p-4-4-justification-of-specifications? , m3-2-p-4-5-excipients-of-human-or-animal-origin? , m3-2-p-4-6-novel-excipients?)> <!ATTLIST m3-2-p-4-control-of-excipients %att; excipient CDATA #IMPLIED > <!ELEMENT m3-2-p-4-1-specifications ((leaf | node-extension)*)> <!ATTLIST m3-2-p-4-1-specifications %att; > <!ELEMENT m3-2-p-4-2-analytical-procedures ((leaf | node-extension)*)> <!ATTLIST m3-2-p-4-2-analytical-procedures %att; > <!ELEMENT m3-2-p-4-3-validation-of-analytical-procedures ((leaf | node-extension)*)> <!ATTLIST m3-2-p-4-3-validation-of-analytical-procedures %att; > <!ELEMENT m3-2-p-4-4-justification-of-specifications ((leaf | node-extension)*)> <!ATTLIST m3-2-p-4-4-justification-of-specifications %att; > <!ELEMENT m3-2-p-4-5-excipients-of-human-or-animal-origin ((leaf | node-extension)*)> <!ATTLIST m3-2-p-4-5-excipients-of-human-or-animal-origin %att; > <!ELEMENT m3-2-p-4-6-novel-excipients ((leaf | node-extension)*)> <!ATTLIST m3-2-p-4-6-novel-excipients %att; > <!ELEMENT m3-2-p-5-control-of-drug-product (leaf* , m3-2-p-5-1-specifications? , m3-2-p-5-2-analytical-procedures? , m3-2-p-5-3-validation-of-analytical-procedures? , m3-2-p-5-4-batch-analyses? , m3-2-p-5-5-characterisation-of-impurities? , m3-2-p-5-6-justification-of-specifications?)> <!ATTLIST m3-2-p-5-control-of-drug-product %att; > <!ELEMENT m3-2-p-5-1-specifications ((leaf | node-extension)*)> <!ATTLIST m3-2-p-5-1-specifications %att; > <!ELEMENT m3-2-p-5-2-analytical-procedures ((leaf | node-extension)*)> <!ATTLIST m3-2-p-5-2-analytical-procedures %att; > <!ELEMENT m3-2-p-5-3-validation-of-analytical-procedures ((leaf | node-extension)*)> <!ATTLIST m3-2-p-5-3-validation-of-analytical-procedures %att; > <!ELEMENT m3-2-p-5-4-batch-analyses ((leaf | node-extension)*)> <!ATTLIST m3-2-p-5-4-batch-analyses %att; > <!ELEMENT m3-2-p-5-5-characterisation-of-impurities ((leaf | node-extension)*)> <!ATTLIST m3-2-p-5-5-characterisation-of-impurities %att; > <!ELEMENT m3-2-p-5-6-justification-of-specifications ((leaf | node-extension)*)> <!ATTLIST m3-2-p-5-6-justification-of-specifications %att; > <!ELEMENT m3-2-p-6-reference-standards-or-materials ((leaf | node-extension)*)> <!ATTLIST m3-2-p-6-reference-standards-or-materials %att; > <!ELEMENT m3-2-p-7-container-closure-system ((leaf | node-extension)*)> <!ATTLIST m3-2-p-7-container-closure-system %att; > <!ELEMENT m3-2-p-8-stability (leaf* , m3-2-p-8-1-stability-summary-and-conclusion? , m3-2-p-8-2-post-approval-stability-protocol-and-stability-commitment? , m3-2-p-8-3-stability-data?)> <!ATTLIST m3-2-p-8-stability %att; > <!ELEMENT m3-2-p-8-1-stability-summary-and-conclusion ((leaf | node-extension)*)> <!ATTLIST m3-2-p-8-1-stability-summary-and-conclusion %att; > <!ELEMENT m3-2-p-8-2-post-approval-stability-protocol-and-stability-commitment ((leaf | node-extension)*)> <!ATTLIST m3-2-p-8-2-post-approval-stability-protocol-and-stability-commitment %att; > <!ELEMENT m3-2-p-8-3-stability-data ((leaf | node-extension)*)> <!ATTLIST m3-2-p-8-3-stability-data %att; > <!ELEMENT m3-2-a-appendices (leaf* , m3-2-a-1-facilities-and-equipment* , m3-2-a-2-adventitious-agents-safety-evaluation* , m3-2-a-3-excipients?)> <!ATTLIST m3-2-a-appendices %att; > <!ELEMENT m3-2-a-1-facilities-and-equipment ((leaf | node-extension)*)> <!ATTLIST m3-2-a-1-facilities-and-equipment %att; manufacturer CDATA #IMPLIED substance CDATA #IMPLIED dosageform CDATA #IMPLIED product-name CDATA #IMPLIED > <!ELEMENT m3-2-a-2-adventitious-agents-safety-evaluation ((leaf | node-extension)*)> <!ATTLIST m3-2-a-2-adventitious-agents-safety-evaluation %att; manufacturer CDATA #IMPLIED substance CDATA #IMPLIED dosageform CDATA #IMPLIED product-name CDATA #IMPLIED > <!ELEMENT m3-2-a-3-excipients ((leaf | node-extension)*)> <!ATTLIST m3-2-a-3-excipients %att; > <!ELEMENT m3-2-r-regional-information ((leaf | node-extension)*)> <!ATTLIST m3-2-r-regional-information %att; > <!ELEMENT m3-3-literature-references ((leaf | node-extension)*)> <!ATTLIST m3-3-literature-references %att; > <!ELEMENT m4-nonclinical-study-reports (leaf* , m4-2-study-reports? , m4-3-literature-references?)> <!ATTLIST m4-nonclinical-study-reports %att; > <!ELEMENT m4-2-study-reports (leaf* , m4-2-1-pharmacology? , m4-2-2-pharmacokinetics? , m4-2-3-toxicology?)> <!ATTLIST m4-2-study-reports %att; > <!ELEMENT m4-2-1-pharmacology (leaf* , m4-2-1-1-primary-pharmacodynamics? , m4-2-1-2-secondary-pharmacodynamics? , m4-2-1-3-safety-pharmacology? , m4-2-1-4-pharmacodynamic-drug-interactions?)> <!ATTLIST m4-2-1-pharmacology %att; > <!ELEMENT m4-2-1-1-primary-pharmacodynamics ((leaf | node-extension)*)> <!ATTLIST m4-2-1-1-primary-pharmacodynamics %att; > <!ELEMENT m4-2-1-2-secondary-pharmacodynamics ((leaf | node-extension)*)> <!ATTLIST m4-2-1-2-secondary-pharmacodynamics %att; > <!ELEMENT m4-2-1-3-safety-pharmacology ((leaf | node-extension)*)> <!ATTLIST m4-2-1-3-safety-pharmacology %att; > <!ELEMENT m4-2-1-4-pharmacodynamic-drug-interactions ((leaf | node-extension)*)> <!ATTLIST m4-2-1-4-pharmacodynamic-drug-interactions %att; > <!ELEMENT m4-2-2-pharmacokinetics (leaf* , m4-2-2-1-analytical-methods-and-validation-reports? , m4-2-2-2-absorption? , m4-2-2-3-distribution? , m4-2-2-4-metabolism? , m4-2-2-5-excretion? , m4-2-2-6-pharmacokinetic-drug-interactions? , m4-2-2-7-other-pharmacokinetic-studies?)> <!ATTLIST m4-2-2-pharmacokinetics %att; > <!ELEMENT m4-2-2-1-analytical-methods-and-validation-reports ((leaf | node-extension)*)> <!ATTLIST m4-2-2-1-analytical-methods-and-validation-reports %att; > <!ELEMENT m4-2-2-2-absorption ((leaf | node-extension)*)> <!ATTLIST m4-2-2-2-absorption %att; > <!ELEMENT m4-2-2-3-distribution ((leaf | node-extension)*)> <!ATTLIST m4-2-2-3-distribution %att; > <!ELEMENT m4-2-2-4-metabolism ((leaf | node-extension)*)> <!ATTLIST m4-2-2-4-metabolism %att; > <!ELEMENT m4-2-2-5-excretion ((leaf | node-extension)*)> <!ATTLIST m4-2-2-5-excretion %att; > <!ELEMENT m4-2-2-6-pharmacokinetic-drug-interactions ((leaf | node-extension)*)> <!ATTLIST m4-2-2-6-pharmacokinetic-drug-interactions %att; > <!ELEMENT m4-2-2-7-other-pharmacokinetic-studies ((leaf | node-extension)*)> <!ATTLIST m4-2-2-7-other-pharmacokinetic-studies %att; > <!ELEMENT m4-2-3-toxicology (leaf* , m4-2-3-1-single-dose-toxicity? , m4-2-3-2-repeat-dose-toxicity? , m4-2-3-3-genotoxicity? , m4-2-3-4-carcinogenicity? , m4-2-3-5-reproductive-and-developmental-toxicity? , m4-2-3-6-local-tolerance? , m4-2-3-7-other-toxicity-studies?)> <!ATTLIST m4-2-3-toxicology %att; > <!ELEMENT m4-2-3-1-single-dose-toxicity ((leaf | node-extension)*)> <!ATTLIST m4-2-3-1-single-dose-toxicity %att; > <!ELEMENT m4-2-3-2-repeat-dose-toxicity ((leaf | node-extension)*)> <!ATTLIST m4-2-3-2-repeat-dose-toxicity %att; > <!ELEMENT m4-2-3-3-genotoxicity (leaf* , m4-2-3-3-1-in-vitro? , m4-2-3-3-2-in-vivo?)> <!ATTLIST m4-2-3-3-genotoxicity %att; > <!ELEMENT m4-2-3-3-1-in-vitro ((leaf | node-extension)*)> <!ATTLIST m4-2-3-3-1-in-vitro %att; > <!ELEMENT m4-2-3-3-2-in-vivo ((leaf | node-extension)*)> <!ATTLIST m4-2-3-3-2-in-vivo %att; > <!ELEMENT m4-2-3-4-carcinogenicity (leaf* , m4-2-3-4-1-long-term-studies? , m4-2-3-4-2-short-or-medium-term-studies? , m4-2-3-4-3-other-studies?)> <!ATTLIST m4-2-3-4-carcinogenicity %att; > <!ELEMENT m4-2-3-4-1-long-term-studies ((leaf | node-extension)*)> <!ATTLIST m4-2-3-4-1-long-term-studies %att; > <!ELEMENT m4-2-3-4-2-short-or-medium-term-studies ((leaf | node-extension)*)> <!ATTLIST m4-2-3-4-2-short-or-medium-term-studies %att; > <!ELEMENT m4-2-3-4-3-other-studies ((leaf | node-extension)*)> <!ATTLIST m4-2-3-4-3-other-studies %att; > <!ELEMENT m4-2-3-5-reproductive-and-developmental-toxicity (leaf* , m4-2-3-5-1-fertility-and-early-embryonic-development? , m4-2-3-5-2-embryo-fetal-development? , m4-2-3-5-3-prenatal-and-postnatal-development-including-maternal-function? , m4-2-3-5-4-studies-in-which-the-offspring-juvenile-animals-are-dosed-and-or-further-evaluated?)> <!ATTLIST m4-2-3-5-reproductive-and-developmental-toxicity %att; > <!ELEMENT m4-2-3-5-1-fertility-and-early-embryonic-development ((leaf | node-extension)*)> <!ATTLIST m4-2-3-5-1-fertility-and-early-embryonic-development %att; > <!ELEMENT m4-2-3-5-2-embryo-fetal-development ((leaf | node-extension)*)> <!ATTLIST m4-2-3-5-2-embryo-fetal-development %att; > <!ELEMENT m4-2-3-5-3-prenatal-and-postnatal-development-including-maternal-function ((leaf | node-extension)*)> <!ATTLIST m4-2-3-5-3-prenatal-and-postnatal-development-including-maternal-function %att; > <!ELEMENT m4-2-3-5-4-studies-in-which-the-offspring-juvenile-animals-are-dosed-and-or-further-evaluated ((leaf | node-extension)*)> <!ATTLIST m4-2-3-5-4-studies-in-which-the-offspring-juvenile-animals-are-dosed-and-or-further-evaluated %att; > <!ELEMENT m4-2-3-6-local-tolerance ((leaf | node-extension)*)> <!ATTLIST m4-2-3-6-local-tolerance %att; > <!ELEMENT m4-2-3-7-other-toxicity-studies (leaf* , m4-2-3-7-1-antigenicity? , m4-2-3-7-2-immunotoxicity? , m4-2-3-7-3-mechanistic-studies? , m4-2-3-7-4-dependence? , m4-2-3-7-5-metabolites? , m4-2-3-7-6-impurities? , m4-2-3-7-7-other?)> <!ATTLIST m4-2-3-7-other-toxicity-studies %att; > <!ELEMENT m4-2-3-7-1-antigenicity ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-1-antigenicity %att; > <!ELEMENT m4-2-3-7-2-immunotoxicity ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-2-immunotoxicity %att; > <!ELEMENT m4-2-3-7-3-mechanistic-studies ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-3-mechanistic-studies %att; > <!ELEMENT m4-2-3-7-4-dependence ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-4-dependence %att; > <!ELEMENT m4-2-3-7-5-metabolites ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-5-metabolites %att; > <!ELEMENT m4-2-3-7-6-impurities ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-6-impurities %att; > <!ELEMENT m4-2-3-7-7-other ((leaf | node-extension)*)> <!ATTLIST m4-2-3-7-7-other %att; > <!ELEMENT m4-3-literature-references ((leaf | node-extension)*)> <!ATTLIST m4-3-literature-references %att; > <!ELEMENT m5-clinical-study-reports (leaf* , m5-2-tabular-listing-of-all-clinical-studies? , m5-3-clinical-study-reports? , m5-4-literature-references?)> <!ATTLIST m5-clinical-study-reports %att; > <!ELEMENT m5-2-tabular-listing-of-all-clinical-studies ((leaf | node-extension)*)> <!ATTLIST m5-2-tabular-listing-of-all-clinical-studies %att; > <!ELEMENT m5-3-clinical-study-reports (leaf* , m5-3-1-reports-of-biopharmaceutic-studies? , m5-3-2-reports-of-studies-pertinent-to-pharmacokinetics-using-human-biomaterials? , m5-3-3-reports-of-human-pharmacokinetics-pk-studies? , m5-3-4-reports-of-human-pharmacodynamics-pd-studies? , m5-3-5-reports-of-efficacy-and-safety-studies* , m5-3-6-reports-of-postmarketing-experience? , m5-3-7-case-report-forms-and-individual-patient-listings?)> <!ATTLIST m5-3-clinical-study-reports %att; > <!ELEMENT m5-3-1-reports-of-biopharmaceutic-studies (leaf* , m5-3-1-1-bioavailability-study-reports? , m5-3-1-2-comparative-ba-and-bioequivalence-study-reports? , m5-3-1-3-in-vitro-in-vivo-correlation-study-reports? , m5-3-1-4-reports-of-bioanalytical-and-analytical-methods-for-human-studies?)> <!ATTLIST m5-3-1-reports-of-biopharmaceutic-studies %att; > <!ELEMENT m5-3-1-1-bioavailability-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-1-1-bioavailability-study-reports %att; > <!ELEMENT m5-3-1-2-comparative-ba-and-bioequivalence-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-1-2-comparative-ba-and-bioequivalence-study-reports %att; > <!ELEMENT m5-3-1-3-in-vitro-in-vivo-correlation-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-1-3-in-vitro-in-vivo-correlation-study-reports %att; > <!ELEMENT m5-3-1-4-reports-of-bioanalytical-and-analytical-methods-for-human-studies ((leaf | node-extension)*)> <!ATTLIST m5-3-1-4-reports-of-bioanalytical-and-analytical-methods-for-human-studies %att; > <!ELEMENT m5-3-2-reports-of-studies-pertinent-to-pharmacokinetics-using-human-biomaterials (leaf* , m5-3-2-1-plasma-protein-binding-study-reports? , m5-3-2-2-reports-of-hepatic-metabolism-and-drug-interaction-studies? , m5-3-2-3-reports-of-studies-using-other-human-biomaterials?)> <!ATTLIST m5-3-2-reports-of-studies-pertinent-to-pharmacokinetics-using-human-biomaterials %att; > <!ELEMENT m5-3-2-1-plasma-protein-binding-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-2-1-plasma-protein-binding-study-reports %att; > <!ELEMENT m5-3-2-2-reports-of-hepatic-metabolism-and-drug-interaction-studies ((leaf | node-extension)*)> <!ATTLIST m5-3-2-2-reports-of-hepatic-metabolism-and-drug-interaction-studies %att; > <!ELEMENT m5-3-2-3-reports-of-studies-using-other-human-biomaterials ((leaf | node-extension)*)> <!ATTLIST m5-3-2-3-reports-of-studies-using-other-human-biomaterials %att; > <!ELEMENT m5-3-3-reports-of-human-pharmacokinetics-pk-studies (leaf* , m5-3-3-1-healthy-subject-pk-and-initial-tolerability-study-reports? , m5-3-3-2-patient-pk-and-initial-tolerability-study-reports? , m5-3-3-3-intrinsic-factor-pk-study-reports? , m5-3-3-4-extrinsic-factor-pk-study-reports? , m5-3-3-5-population-pk-study-reports?)> <!ATTLIST m5-3-3-reports-of-human-pharmacokinetics-pk-studies %att; > <!ELEMENT m5-3-3-1-healthy-subject-pk-and-initial-tolerability-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-3-1-healthy-subject-pk-and-initial-tolerability-study-reports %att; > <!ELEMENT m5-3-3-2-patient-pk-and-initial-tolerability-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-3-2-patient-pk-and-initial-tolerability-study-reports %att; > <!ELEMENT m5-3-3-3-intrinsic-factor-pk-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-3-3-intrinsic-factor-pk-study-reports %att; > <!ELEMENT m5-3-3-4-extrinsic-factor-pk-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-3-4-extrinsic-factor-pk-study-reports %att; > <!ELEMENT m5-3-3-5-population-pk-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-3-5-population-pk-study-reports %att; > <!ELEMENT m5-3-4-reports-of-human-pharmacodynamics-pd-studies (leaf* , m5-3-4-1-healthy-subject-pd-and-pk-pd-study-reports? , m5-3-4-2-patient-pd-and-pk-pd-study-reports?)> <!ATTLIST m5-3-4-reports-of-human-pharmacodynamics-pd-studies %att; > <!ELEMENT m5-3-4-1-healthy-subject-pd-and-pk-pd-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-4-1-healthy-subject-pd-and-pk-pd-study-reports %att; > <!ELEMENT m5-3-4-2-patient-pd-and-pk-pd-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-4-2-patient-pd-and-pk-pd-study-reports %att; > <!ELEMENT m5-3-5-reports-of-efficacy-and-safety-studies (leaf* , m5-3-5-1-study-reports-of-controlled-clinical-studies-pertinent-to-the-claimed-indication? , m5-3-5-2-study-reports-of-uncontrolled-clinical-studies? , m5-3-5-3-reports-of-analyses-of-data-from-more-than-one-study? , m5-3-5-4-other-study-reports?)> <!ATTLIST m5-3-5-reports-of-efficacy-and-safety-studies %att; indication CDATA #IMPLIED > <!ELEMENT m5-3-5-1-study-reports-of-controlled-clinical-studies-pertinent-to-the-claimed-indication ((leaf | node-extension)*)> <!ATTLIST m5-3-5-1-study-reports-of-controlled-clinical-studies-pertinent-to-the-claimed-indication %att; > <!ELEMENT m5-3-5-2-study-reports-of-uncontrolled-clinical-studies ((leaf | node-extension)*)> <!ATTLIST m5-3-5-2-study-reports-of-uncontrolled-clinical-studies %att; > <!ELEMENT m5-3-5-3-reports-of-analyses-of-data-from-more-than-one-study ((leaf | node-extension)*)> <!ATTLIST m5-3-5-3-reports-of-analyses-of-data-from-more-than-one-study %att; > <!ELEMENT m5-3-5-4-other-study-reports ((leaf | node-extension)*)> <!ATTLIST m5-3-5-4-other-study-reports %att; > <!ELEMENT m5-3-6-reports-of-postmarketing-experience ((leaf | node-extension)*)> <!ATTLIST m5-3-6-reports-of-postmarketing-experience %att; > <!ELEMENT m5-3-7-case-report-forms-and-individual-patient-listings ((leaf | node-extension)*)> <!ATTLIST m5-3-7-case-report-forms-and-individual-patient-listings %att; > <!ELEMENT m5-4-literature-references ((leaf | node-extension)*)> <!ATTLIST m5-4-literature-references %att; >
Prepared by Robin Cover for The XML Cover Pages archive.