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- Q1116233 subject Q13252734.
- Q1116233 subject Q6933255.
- Q1116233 abstract "The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (FDA, US) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).The Common Technical Document is divided into five modules: Administrative and prescribing information Overview and summary of modules 3 to 5 Quality (pharmaceutical documentation) Preclinical (Pharmacology/Toxicology) Clinical – efficacy (Clinical Trials)Detailed subheadings for each Module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of other Modules will differ, based on national requirements.After the United States, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland.The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD.".
- Q1116233 thumbnail CTD-img004.png?width=300.
- Q1116233 wikiPageExternalLink www.ich.org.
- Q1116233 wikiPageExternalLink ctd.html.
- Q1116233 wikiPageWikiLink Q1191238.
- Q1116233 wikiPageWikiLink Q130146.
- Q1116233 wikiPageWikiLink Q13252734.
- Q1116233 wikiPageWikiLink Q1666462.
- Q1116233 wikiPageWikiLink Q204711.
- Q1116233 wikiPageWikiLink Q288914.
- Q1116233 wikiPageWikiLink Q30612.
- Q1116233 wikiPageWikiLink Q571067.
- Q1116233 wikiPageWikiLink Q6933255.
- Q1116233 comment "The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.".
- Q1116233 label "Common Technical Document".
- Q1116233 depiction CTD-img004.png.