- 同
- CTD
WordNet
- to be expected; standard; "common decency"
- common to or shared by two or more parties; "a common friend"; "the mutual interests of management and labor" (同)mutual
- of or associated with the great masses of people; "the common people in those days suffered greatly"; "behavior that branded him as common"; "his square plebeian nose"; "a vulgar and objectionable person"; "the unwashed masses" (同)plebeian, vulgar, unwashed
- commonly encountered; "a common (or familiar) complaint"; "the usual greeting" (同)usual
- being or characteristic of or appropriate to everyday language; "common parlance"; "a vernacular term"; "vernacular speakers"; "the vulgar tongue of the masses"; "the technical and vulgar names for an animal species" (同)vernacular, vulgar
- belonging to or participated in by a community as a whole; public; "for the common good"; "common lands are set aside for use by all members of a community"
- having no special distinction or quality; widely known or commonly encountered; average or ordinary or usual; "the common man"; "a common sailor"; "the common cold"; "a common nuisance"; "followed common procedure"; "it is common knowledge that she lives alone"; "the common housefly"; "a common brand of soap"
- resulting from or dependent on market factors rather than fundamental economic considerations; "analysts content that the stock market is due for a technical rally"; "the fall is only a technical correction"
- a pickup truck with a gun mounted on it
- of or relating to or requiring special knowledge to be understood; "technical terminology"; "a technical report"; "technical language" (同)expert
- of or relating to technique or proficiency in a practical skill; "his technical innovation was his brushwork"; "the technical dazzle of her dancing" (同)proficient
- of or relating to a practical subject that is organized according to scientific principles; "technical college"; "technological development" (同)technological
- characterizing or showing skill in or specialized knowledge of applied arts and sciences; "a technical problem"; "highly technical matters hardly suitable for the general public"; "a technical report"; "producing the A-bomb was a challenge to the technical people of this country"; "technical training"; "technical language"
- support or supply with references; "Can you document your claims?"
- a written account of ownership or obligation
- anything serving as a representation of a persons thinking by means of symbolic marks
- writing that provides information (especially information of an official nature) (同)written document, papers
- record in detail; "The parents documented every step of their childs development"
PrepTutorEJDIC
- (二つ以上のものに)『共通の』,共同の,共有の / 『一般の』,公共の,公衆の / 『普通の』,ありふれた / 慢凡な,並みの / 品のない,粗野な,野卑な(vulgar) / (数式で)共通の,公約の通約の・ (文法で)通性の,通格の(男性・女性どちらの格も用いることができる) ・〈C〉《時に複数形で》共有地,公有地,共有牧草;(市町村の)公園・〈U〉共有権
- 『専門の』,専門的な / 『工業の』,工芸の / 技術の,技術上の
- (証書・記録・資料などの)『文書』,書類 / …‘を'事実(証拠)で裏づける
Wikipedia preview
出典(authority):フリー百科事典『ウィキペディア(Wikipedia)』「2015/11/09 11:55:56」(JST)
[Wiki en表示]
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).[1]
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.
See also
- Harmonization in clinical trials
- eCTD
- Clinical Data Interchange Standards Consortium
- Clinical trial
External links
- ICH
- Common Technical Document
References
- ^ http://www.fda.gov/cber/gdlns/m4ctd.pdf "Guidance for Industry, ICH M4: Organization of the CTD" U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) August 2001
UpToDate Contents
全文を閲覧するには購読必要です。 To read the full text you will need to subscribe.
English Journal
- Assessing residents' operative skills for external ventricular drain placement and shunt surgery in pediatric neurosurgery.
- Aldave G1, Hansen D1, Briceño V1, Luerssen TG1, Jea A1,2.
- Journal of neurosurgery. Pediatrics.J Neurosurg Pediatr.2017 Jan 27:1-7. doi: 10.3171/2016.10.PEDS16471. [Epub ahead of print]
- OBJECTIVE The authors previously demonstrated the use of a validated Objective Structured Assessment of Technical Skills (OSATS) tool for evaluating residents' operative skills in pediatric neurosurgery. However, no benchmarks have been established for specific pediatric procedures despite an increa
- PMID 28128705
- 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung.
- Graham BL1, Brusasco V2, Burgos F3, Cooper BG4, Jensen R5, Kendrick A6, MacIntyre NR7, Thompson BR8, Wanger J9.
- The European respiratory journal.Eur Respir J.2017 Jan 3;49(1). pii: 1600016. doi: 10.1183/13993003.00016-2016. Print 2017 Jan.
- This document provides an update to the European Respiratory Society (ERS)/American Thoracic Society (ATS) technical standards for single-breath carbon monoxide uptake in the lung that was last updated in 2005. Although both DLCO (diffusing capacity) and TLCO (transfer factor) are valid terms to des
- PMID 28049168
- Executive Summary: 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung.
- Graham BL1, Brusasco V2, Burgos F3, Cooper BG4, Jensen R5, Kendrick A6, MacIntyre NR7, Thompson BR8, Wanger J9.
- The European respiratory journal.Eur Respir J.2017 Jan 3;49(1). pii: 16E0016. doi: 10.1183/13993003.E0016-2016. Print 2017 Jan.
- This document summarises an update to the European Respiratory Society (ERS)/American Thoracic Society (ATS) technical standards for single-breath carbon monoxide uptake in the lung that was last updated in 2005. The full standards are also available online as https://doi.org/10.1183/13993003.00016-
- PMID 28049167
Japanese Journal
- ICH活動の開発戦略へのImpact-Efficacyガイドライン検討を中心に-
- 医薬品評価におけるバイオマーカー利用に向けたPMDAの取り組み
Related Links
- M4 : The Common Technical Document The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review ...
- 患者の為の治験・臨床試験ポータルサイト。患者サイドに立って治験及び臨床試験に関する情報を提供。 ... CTD CTD(Common Technical Document コモン・テクニカル・ドキュメント) 日米EU医薬品規制調和国際会議(ICH)で ...
★リンクテーブル★
[★]
- 関
- carboxy-terminal domain
- 関
- See Carboxyl terminal repeat domain
- 関
- Common Technical Document
[★]
- 英
- carboxy-terminal domain、CTD
-CTD
- 関
- See Carboxyl terminal repeat domain
- 関
- Common Technical Document
[★]
- 関
- corroborate、demonstrate、demonstration、describe、description、descriptive、documentation、note、substantiate、substantiation、writing
[★]
- 関
- commonly、conventional、general、generally、in general、normal、normally、ordinarily、ordinary、total、usual、usually
[★]
- 関
- skill、technic、technically、technique、technologic