post-marketing surveillance

• 市販後調査

関

pharmacovigilance

WordNet

1. ride Western style and bob up and down in the saddle in rhythm with a horses trotting gait
2. an upright consisting of a piece of timber or metal fixed firmly in an upright position; "he set a row of posts in the ground and strung barbwire between them"
3. the delivery and collection of letters and packages; "it came by the first post"; "if you hurry youll catch the post"
4. a pole or stake set up to mark something (as the start or end of a race track); "a pair of posts marked the goal"; "the corner of the lot was indicated by a stake" (同)stake
5. the position where someone (as a guard or sentry) stands or is assigned to stand; "a soldier manned the entrance post"; "a sentry station" (同)station
6. mark or expose as infamous; "She was branded a loose woman" (同)brand
7. transfer (entries) from one account book to another (同)carry
8. place so as to be noticed; "post a sign"; "post a warning at the dump" (同)put_up
9. affix in a public place or for public notice; "post a warning"
10. assign to a post; put into a post; "The newspaper posted him in Timbuktu"
11. display, as of records in sports games
12. enter on a public list
13. publicize with, or as if with, a poster; "Ill post the news on the bulletin board"
14. close observation of a person or group (usually by the police)
15. shopping at a market; "does the weekly marketing at the supermarket"
16. the commercial processes involved in promoting and selling and distributing a product or service; "most companies have a manager in charge of marketing"
17. United States manufacturer of breakfast cereals and Postum (1854-1914) (同)C. W. Post, Charles William Post
18. United States female author who wrote a book and a syndicated newspaper column on etiquette (1872-1960) (同)Emily Post, Emily Price Post
19. United States aviator who in 1933 made the first solo flight around the world (1899-1935) (同)Wiley Post
20. (bookkeeping) a listing on the companys records; "the posting was made in the cash account"

PrepTutorEJDIC

1. 〈C〉(木・金属・石などの)『柱』,『支柱』,くい / 《the ~》(競馬の)出発標,決勝標 / 〈C〉《話》(ラグビーなどの)ゴールポスト(goalpost) / (柱・壁などに)〈掲示物〉‘を'『張る』,張り出す《+『名』〈掲示物〉+『on』+『名』》;(掲示物を)〈柱・壁など〉‘に'張る《+『名』+『with』+『名』〈掲示物〉》 / (掲示して)…‘を'公表する,公示する / 《通例受動態で》(…として)…‘を'掲示(発表)する《+『名』+『as』+『現分』(過分)》
2. (兵士・警官・看護婦などの)『部署』,『持ち場』 / (軍隊の)駐屯(ちゅうとん)地,駐留地,兵営地 / (指名・任命された)『地位』,職 / (またtrading post)(未開地などの)交易所 / 〈兵士・警官・看護婦など〉‘を'配置する / 《通例受動態で》《おもに英》(…に)〈人〉‘を'任命する《+『名』+『to』+『名』》
3. 〈U〉《おもに英》『郵便』[制度] / 《おもに英》《単数形で》(郵便物の1回の)『集配』,『配達』,便;(1回で集配・配達される)郵便物(《米》mail) / 《the ~》《おもに英》郵便局(post office);ポスト,郵便箱(《米》mailbox) / 〈C〉(昔,郵便物の中断所にした)駅,宿,宿場 / 《おもに英》〈郵便物〉‘を'郵便局に出す,ポストに入れる(《米》mail)《+『off』+『名』+『,』『名』+『off』》 / 《『post』+『名』〈間〉〈人〉+『名』〈直〉=『post』+『名』+『to』+『名』〈人〉》〈人〉‘に'〈手紙など〉‘を'郵便で送る(《米》mail)
4. (特に容疑者・囚人などの)監視,見張り / 監督,指揮
5. 市場での売買[取引き] / マーケディング(宣伝・販売・技術などを研究する経営学の分野)
6. 《おもに英》(特に軍職に)任命すること

Wikipedia preview

出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2015/01/18 17:06:04」(JST)

wiki en

[Wiki en表示]

Postmarketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose - meaning that they normally do not have other medical conditions which may exist in the general population - postmarketing surveillance can further refine, or confirm or deny, the safety of a drug after it is used in the general population by large numbers of people who have a wide variety of medical conditions.

Postmarketing surveillance uses a number of approaches to monitor the safety of licensed drugs, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries and record linkage between health databases. These data are reviewed to highlight potential safety concerns in a process known as data mining.

National Implementation

Canada: Health Canada is the regulatory body which approves drugs, and it has a division called "Marketed Health Products Directorate" (MHPD) which coordinates Canadian postmarketing surveillance.

United Kingdom: The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) jointly operate the Yellow Card Scheme, which was one of the first examples of a Pharmacovigilance scheme, aimed at mitigating Adverse Drug Reactions (ADRs)

United States: Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs.

Footnotes

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English Journal

• Market surveillance of in vitro diagnostics by the BfArM until end 2010: how safe are products for tumor diagnostics?

• Siekmeier R, Wetzel D.SourceDepartment of Medical Products, Federal Institute for Drugs and Medical Devices, Bonn, Germany. Ruediger.Siekmeier@bfarm.de
• Advances in experimental medicine and biology.Adv Exp Med Biol.2013;755:385-96.
• The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) regulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions the manufacturers have to inform the responsible Competent Authorities (CA). In G
• PMID 22826091

• Market surveillance of in vitro diagnostics by the BfArM until end 2010: safety of IVD for therapeutic drug monitoring.

• Siekmeier R, Wetzel D.SourceDepartment of Medical Products, Federal Institute for Drugs and Medical Devices, Bonn, Germany. Ruediger.Siekmeier@bfarm.de
• Advances in experimental medicine and biology.Adv Exp Med Biol.2013;755:375-83.
• The European Directive 98/79/EC on in vitro diagnostic medical devices (IVD) regulates the marketing and post market surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions, the manufacturers have to inform the responsible Competent Authorities (CA). In
• PMID 22826090

Japanese Journal

• 肝がん ソラフェニブの新たな展開(適応承認後明らかになってきた治療成績,課題,新たな臨床試験など) (特集 肝・胆・膵腫瘍の薬物療法 : 最近の進歩)

• 山下 竜也,荒井 邦明,金子 周一
• 腫瘍内科 9(6), 641-650, 2012-06
• NAID 40019379967

• Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis

• Koike Takao,Harigai Masayoshi,Inokuma Shigeko,Ishiguro Naoki,Ryu Junnosuke,Takeuchi Tsutomu,Tanaka Yoshiya,Yamanaka Hisashi,Fujii Koichi,Yoshinaga Takunari,Freundlich Bruce,Suzukawa Michio
• Rheumatology International 32(6), 1511-1519, 2012-06
• … Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. …
• NAID 120004405518

Related Links

• Post-marketing Surveillance of Drugs - 日本製薬工業協会

Pharmaceutical Regulations in Japan: 2012-3 - 142 - (5) Standard operating procedures for post-marketing surveillance (Article 5) [1] The following standard operating procedures for post-marketing safety management must be ...

• 市販後調査（PMS：Post Marketing Surveillance）

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。 ... 市販後調査（PMS） 市販後調査（PMS：Post Marketing Surveillance） 市販後（新薬発売後）に医薬品製造業者が行う調査で、

Related Pictures

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★リンクテーブル★

リンク元	「市販後調査」「pharmacovigilance」
関連記事	「surveillance」「post」「marketing」

「市販後調査」

　　[★]

英

pharmacovigilance、post-marketing surveillance

同

PMS

関

ファーマコビジランス、医薬品安全性監視

「pharmacovigilance」

　　[★]

• 医薬品安全性監視、ファーマコビジランス、市販後調査

関

post-marketing surveillance

「surveillance」

　　[★]

• n.

• サーベイランス、調査、監視、調査監視

関

examine、exploration、explore、guard、inquire、inquiry、investigate、investigation、investigational、investigative、monitoring、oversight、probing、research、scan、scrutiny、study、survey

　 　

「post」

　　[★]

• comb form.

• ポスト、後

• v.

• ポストする

関

after、afterward、afterwards、behind、following、late、posterior、subsequent

　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　

「marketing」

　　[★]

• 市販、出荷、マーケティング

関

commercial、market