關於 orphan drug中文 ，我們在網路上蒐集到這些相關的討論、資訊與評價

#11. 孤兒藥 - 中文百科知識

孤兒藥（Orphan drug）是指患病人群不到10萬（又20萬）人的疾病治療藥物。對孤兒藥的認定需同時滿足多個標準，包括疾病的嚴重性，其它診斷、預防或治療的方法是否存在 ...

#12. 專利情報： 兩條腿走路：淺論新藥保護的兩個機制

除了特別的「孤兒藥」（orphan drug）外，「市場專有」並不常見；「市場獨佔」一詞則從來沒出現在任何法規上；; 核批專有：這個中文名詞乃筆者自創， ...

#13. orphan drug 中文- 英文词典

orphan drug 中文 · 孤儿药（英语：Orphan drug，亦称为罕用药）指的是一些專門用於治癒（cure）或治療（控制，treat）罕见疾病的特效药物。 · 例如治療龐貝氏症的藥物 ...

#14. 求科普：美国的《孤儿药法案》（Orphan Drug Act）是 ... - 译问

今天，是余生的第一天。 ... 哈哈，当然不是的。 孤儿药（Ophan Drug）是指用于诊断、治疗和预防罕见病的药品，而罕见病是一类发病率极低的疾病的总称，又被称为“孤儿病”。

#15. 選定地方的罕見疾病政策 - 立法會

A.I.1. In the US, the federal government enacted as early as in 1983 the. Orphan Drug Act to support the medical treatment of rare disease patients. As ...

#16. 促進基因治療產品開發！ 美國FDA公布六項指引及一項草案

... 其安全性與有效性，美國食品藥品管理局( Food & Drug Administration, ... Gene Therapy Products under the Orphan Drug Regulations ) 草案。

#17. 罕見疾病用藥之相關法規檢視【本期企劃】,月旦醫事法網

Reviewing the Regulations of Rare Diseases and Orphan Drugs. 作者. 洪瑜黛. 中文 ... Since the implementation of Rare Disease and Orphan Drug Act is in Aug.

#18. The Rare Disease and Orphan Drug Act - Article Content

The term orphan drugs as used in this Act shall refer to drugs with major indications for the prevention, diagnosis and treatment of rare diseases that have ...

#19. Search Orphan Drug Designations and Approvals

This page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan designation, and dates.

#20. 翻译'orphan drug' – 字典中文-英文

Orphanet is a European website providing information about orphan drugs and rare diseases. Orphanet 是一個提供孤兒藥物及罕見疾病信息的歐洲網站。 LASER- ...

#21. 【篤實關懷倫理卓越】光田綜合醫院Kuang Tien General Hospital

中文 名, 賽得膠囊, 健保局藥理類別, 92240000 Biologic response modifiers ... 美國FDA亦核可此藥品作為治療下列疾病之孤兒藥(orphan drug)：治療或預防骨髓移植 ...

#22. 孤儿-翻译为英语-例句中文 - Reverso Context

The direction of research: "orphan crops". 又兴建海洋博物馆，帮助孤儿. He built a maritime museum and a new wing for the orphanage. 父母双亡（自然孤儿）；.

#23. 新藥查驗登記- 藥品審查

財團法人醫藥品查驗中心. * 回首頁 * 網站導覽 * 中文版 * ... (2) 具醫療迫切需求，且在十大醫藥先進國 * 之任一國已取得罕藥認定（Orphan drug designation）。

#24. drug中文(繁體)翻譯：劍橋詞典

drug 翻譯：藥, 藥，藥物，藥品, 非法物質, 毒品；興奮劑, 成癮之事, ... orphan drugs and (ii) funding the development and use of orphan drugs.

#25. 衛生福利部國民健康署- Rare Disease and Orphan Drug Act

3.An orphan drug distribution center was established and stocked with nine kinds of drugs urgently needed by rare disease patients. 4.A rare disease special ...

#26. 困難不代表束手無策——「孤兒藥」價高企現象要如何解決？

... 不願為患者不多的「蚊型」市場研發藥物，令患者「無藥可醫」，遂訂立法例，透過優惠措施鼓勵藥商研發這類不受關注的「孤兒藥」（orphan drug）。

#27. Orphan Drug Designation List - Health Resources and ...

Orphan Drugs. For rural referral centers, sole community hospitals, critical access hospitals, and free-standing cancer hospitals participating in the 340B ...

#28. orphan drug的中文是什麼意思

orphan drug 的中文是什麼意思，orphan drug的中文翻譯_例句. 搜尋表單. English, orphan drug. 中文, 孤兒藥. determining orphan drug eligibility for reduced ...

#29. 美国ACCDON公司旗下品牌 - SCI论文修改

推荐同事 机构合作 中文 繁體中文 English 한국어 日本語 Português Español. 美国ACCDON公司旗下品牌 ... 中英对照. 罕用药. orphan drug. 学科分类.

#30. 新藥查驗登記加速核准機制

取得罕藥認定（Orphan drug designation）。 ... (一) 適用本機制核准之藥品，中文仿單適應症段落需加入下列文字. 敘述：此適應症係依據(…[填寫替代療效指標，例如： ...

#31. 參加美國食品藥物管理局生物製劑研究暨評估中心（CBER ...

美國美國食品藥物管理局（Food and Drug Administration, FDA）生物製劑評 ... 1983 年，美國國會制定孤兒藥法案（Orphan Drug Act），獎勵藥廠針對罕見.

#32. orphan disease 中文意思是什麼 - Dict.site 線上英文字典

orphan disease 中文意思是什麼 · orphan : n adj 孤兒（的），沒有父母（或其中之一）的（孩子）。vt 〈常用被動語態〉使成孤兒。 an orphan asylu... · disease : n. 1. 病 ...

#33. 驯鹿医疗CT120全人源双靶点产品获美国FDA孤儿药认定公司新闻

孤儿药认定（Orphan Drug Designation, ODD）是FDA 孤儿药产品开发办公室（Office of Orphan Products Development, OOPD）对符合条件的用于预防、 ...

#34. 罕見病不罕見

彭博商業周刊/中文版 ... 藥物也被稱為「孤兒藥」（Orphan drug），顧名思義，這類藥 ... 美國在1983年制定《孤兒藥品法》（Orphan Drug Act），.

#35. 藥品專利連結制度與競爭法規範之研究 - 公平交易委員會

之韓文原文版本進行中文之意譯供參，並非正式翻譯，謹此續明，「韓國藥事法原文 ... 孤兒藥（orphan drugs）銷售專屬期（market exclusivity）兩類別，前者係對專.

#36. PD-L1抗体KN035被美国FDA授予孤儿药资格 - 康宁杰瑞

美国FDA“孤儿药资格认定”源自《孤儿药法案》（Orphan Drug Act，ODA），是FDA鼓励开发在美国患病人数低于20 万疾病的创新药措施。

#37. 上海君實生物醫藥科技股份有限公司

員工入口 中文简体 中文繁体 EN ... 中文简体 中文繁体 EN ... 食管癌（EC）獲得美國食品藥品監督管理局（FDA）授予的孤兒藥資格認定（Orphan-drug Designation）。

#38. Ibalizumab (TMB-355) Intravenous Infusion - TaiMed Biologics

U.S. FDA granted orphan drug designation of ibalizumab for HIV patients with multidrug resistance in 2014. Moreover, TaiMed received breakthrough therapy ...

#39. 复星医药在研白血病治疗新药FN-1501获美国孤儿药认定

... 复星医药产业发展有限公司在研白血病治疗新药FN-1501获得美国食品药品监督管理局（以下简称“美国FDA”）孤儿药认定（Orphan Drug Designation）。

#40. Orphan Drugs: Research and Reviews | Volume 4 - Dove ...

An international, peer-reviewed, open access journal publishing original research, reports, reviews and commentaries on all areas of the design and ...

#41. Patients with Catastrophic Illnesses or Rare Diseases

... Disease Control and Orphan Drug Act,” it must be reviewed on a special-case basis by the National Health Insurance Administration before it can be used.

#42. Taiwan Drug Approval Process- Ministry of Health and Welfare

Taiwan Food and Drug Administration (TFDA) recently announced several new ... for a drug which addresses unmet medical need with orphan drug ...

#43. PHN013 (Orphan drug;ITP) - 懷特生技新藥

The product has been granted Orphan Drug Designation for the treatment of immune thrombocytopenic purpura, and will soon enter the priority review process, ...

#44. RAC考試中文線上課程 - 美國醫療法規學會(RAPS)台灣分會

g.generic drug products and biosimilars h.principles of orphan drugs i.food supplements and cosmetic products j.veterinary medicinal products

#45. AJ201 tw – 安基生技新藥

Dedicated to New Drug Development in Dermatology & Neurology ... AJ201獲得美國FDA 三種孤兒藥資格(orphan drug designation)，分別適用於治療SBMA，HD和SCA。

#46. Latham Scores Major Orphan Drug Exclusivity Win for Catalyst ...

Orphan drugs treat “rare diseases or conditions” and Congress created a ... Once a drug is designated by FDA as an orphan drug and approved, ...

#47. CENTOGENE | LinkedIn

... bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge and data.

#48. 韩国针对孤儿药的国家药品清单上市流程：叙述性评论着眼于 ...

Expert Opinion on Orphan Drugs ( IF 0.694 ) Pub Date : 2021-04-12 , DOI: 10.1080/21678707.2021.1913121. Joon Seok Bang, Jong Hyuk Lee.

#49. Amplia Therapeutics公司被授予治疗胰腺癌的FDA孤儿药资格 ...

Amplia Therapeutics ASX ATX FDA Amplia orphan drug designation pancreatic cancer Amplia计划在2021年开始对AMP945在癌症患者中的第一阶段的临床 ...

#50. Orphan Diseases - DET365中文网站- beat365中文官方网站

... drug development, clinical trials, regulatory affairs, funding or the commercialization of orphan disease therapies and cures. 聚会地点.

#51. Dantrolene Sodium 【I1DAN】Dantrolen IV® 20mg/Vial ATC ...

中文 名： 蘭特益靜脈注射液«富洋». 適應症： 治療惡性高熱症。 ... Dantrolene 列屬孤兒藥(orphan drug)，高屏地區庫存醫院有高醫、高榮、高雄長.

#52. Orphanage 释义| 柯林斯英语词典

an institution for the housing and care of orphans ... 美式英语: orphanage /ˈɔrfənɪdʒ/; 巴西葡萄牙语: orfanato; 简体中文: 孤儿院; 欧洲西班牙语: orfanato ...

#53. Orphan Drugs - 博客來

書名：Orphan Drugs，語言：英文，ISBN：9781907568091，頁數：334，作者：Hernberg-stahl, Elizabeth/ Reljanovic, Miroslav，出版日期：2013/10/23，類別：自然科普.

#54. 罕见病患者CEO加入“孤儿药开发指南”课题组 - ReflectionBio

... Rare Diseases Research Consortium, 简称IRDiRC) 的邀请，加入该联盟新组建的“孤儿药研发指南” 课题组(“Orphan Drug Development Guidebook” Task Force)。

#55. EU Court Upholds the Scope of Orphan Drug Designation

Regulation 141/2000 on orphan medicinal products (the Orphan Regulation) provides vital incentives to stimulate the development of treatments ...

#56. 美国孤儿药开发的政策、策略与实践

孤儿药（orphan drug）是用于预防、诊断、治疗罕 ... 《中国药科大学学报》是由国家教育部主管、中国药科大学主办的中文药学核心期刊，主要刊登合成 ...

#57. Orphan Drugs - Hogan Lovells

Orphan Drugs. Developing Drugs and Biologics to Treat Rare Diseases. We have a proven track record of helping clients obtain and benefit from orphan drug ...

#58. About Form 8820, Orphan Drug Credit - IRS

Use this form to claim the orphan drug credit. The credit is 50% of qualified clinical testing expenses paid or incurred during the tax year ...

#59. orphan — 中文翻译- TechDico辞書

R&d and market size: who benefits from orphan drug regulation?Since the early 80s, orphan drug regulations have been introduced to stimulate R&D for rare ...

#60. Initiation of a Phase 2 Multicenter Study of 18F-APN-1607, a ...

APRINOIA's lead tau PET imaging tracer, APN-1607 (PM-PBB3), has received US FDA Orphan Drug Designation. December 15, 2017. APRNIOIA ...

#61. Welcome to SyneuRx US

中文. SyneuRx Announces Oral COVID-19 Twindemic Antiviral Drug Candidate ... and Orphan Drug Designation' grants by the FDA for its CNS drug candidates.

#62. 基石药业宣布PD-1抗体CS1003被美国FDA授予孤儿药资格

美国FDA“孤儿药资格认定”源自《孤儿药法案》（Orphan Drug Act，ODA），是FDA鼓励开发用于治疗罕见病创新药的措施。凡获得孤儿药资格认定的新药，有 ...

#63. 'Orphan Drug' Loophole Needs Closing, Johns Hopkins ...

Health experts at Johns Hopkins Medicine are calling on lawmakers and regulators to close loopholes in the Orphan Drug Act they claim give ...

#64. Orphan drug protection: clarification needed - Taylor Wessing

The most powerful exclusivity right available to medicinal products after patent protection is orphan drug status. But although the clinical ...

#65. MammaPrint+BluePeint欣扶妳乳癌腫瘤基因雙效檢測

YBE has been marketing oncology products and orphan drugs in Taiwan over ten years, ... with the medical professionals in drug and medical device fields, ...

#66. 340B Drug Pricing Program Orphan Drugs ... - HHS.gov

Orphan Drugs. For rural referral centers, sole community hospitals, critical access hospitals, and free-standing cancer hospitals participating ...

#67. 什麼是人道用途器材(HUD)和人道用途醫材豁免(HDE)?

如果對照到藥品來看的話，相似的專有名詞就是孤兒藥或罕見疾病藥(Orphan Drug)。那HUD和HDE有什麼不同嗎? 簡單來說，HUD是指人道用途的醫材，而HDE則 ...

#68. Company History - 景凱生技

TaiwanJ was approved by the Ministry of Economy as a "new drugs biotech company". ... FDA granted orphan drug designation for using JKB-122 to treat AIH.

#69. Rare Diseases & Orphan Drugs - Medunik USA

Pharmaceutical Executive). What Is an Orphan Drug? Orphan drugs are medications or other medicinal products used to treat rare diseases ...

#70. 腫瘤伴生神經症候群 - 藥學雜誌電子報130期

US Food and Drug Administration: Search Orphan Drug Designations and Approvals; www.fda.gov; Accessed 19 Jun 2016. 4. Giometto B, Grisold W, ...

#71. 340B Orphan Drug Interpretive Rule Struck Down by D.C. ...

Orphan drugs are drugs developed to treat a rare disease or condition—often referred to as an orphan disease. Prior to seeking Food and Drug ...

#72. CMC（Chemistry, Manufacturing, Control） - 生技投資第一站

... 研發中最關鍵的技術，若沒有CMC科學研究的支持，各國醫藥主管機關不會同意進行人體臨床試驗。 上一篇. Autoimmune disease · 下一篇. Orphan drug ...

#73. One Pharma Fix: Limit the 'Orphan Drug' Incentives - WSJ

Extended monopolies on drugs for orphan diseases—as those affecting fewer than 200,000 people in the U.S. are known—allow pharmaceutical ...

#74. Jazz Pharmaceuticals' Xywav Granted Orphan Drug Exclusivity

The Orphan Drug Designation program is devised to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. ...

#75. Cochrane Library: Cochrane Reviews

The Cochrane Library is a collection of high-quality, independent evidence to inform healthcare decision-making. Six databases are available including the ...

#76. Alexion Pharmaceuticals Inc. - The New York Times

Drugs to treat rare diseases can be gold mines for pharmaceutical companies. ... The deal taps into the interest for so-called orphan drugs, where companies ...

#77. Everest Medicines Announces Taiwan FDA Has Accepted ...

SHANGHAI, Jan. 4, 2022 /PRNewswire/ -- Everest Medicines Announces Taiwan FDA Has Accepted New Drug Application for Sacituzumab Govitecan in ...

#78. Home - Veloxis - Transplant Patients

Veloxis is a specialty pharmaceutical company committed to improving the lives of transplant patients.

#79. Overview of Orphan Drug/Medical Device Designation System

Orphan Drug /Medical Device Designation. In Japan, drugs and medical devices can be designated as orphan drugs or medical devices based on the Article ...

#80. Positive EMA opinion for the use of Teysuno in metastatic ...

... and commercialization of specialty products, which include niche hospital and orphan products, to address unmet medical needs.

#81. What to read after Harry Potter. Seven magical book ... - ABC

Young orphan girl Lyra goes on a quest to find her missing friends. She discovers secrets involving a secretive group of the church and ...

#82. Dead baby club - Pairview

... body outline drug overdose - dead body stock illustrations. ... In 2021 Since its inception in 1924, Little Orphan Annie has become an American icon.

#83. UNICEF

UNICEF works in more than 190 countries and territories to reach the most disadvantaged children and adolescents – and to protect the rights of every child, ...

#84. Genetics and Rare Diseases Center - 中國醫藥大學附設醫院

... pursuant to the Rare Disease and Orphan Drug Act and pertinent regulations, has set up the Special Nutritional Food and Emergency Drug Logistics Center ...

#85. Pku client education - Free Web Hosting - Your Website need ...

Issues generally related to: bio-pharmaceutical drugs and drug development programs, including but not limited to Orphan Drug Act incentives, ...

#86. Latest Information and Resources | COVID-19 - Ohio ...

... U.S. Food and Drug Administration and the CDC have recommended that use of the Johnson & Johnson (Janssen) COVID-19 vaccine can resume.

#87. Gregory mevs family - Dilesa

Tiếng Trung Phồn Thể - 傳統中文. ... transported by the Manzanares ship in which the drugs were found in April 2015, has been "charged" and Sébastien ...

#88. Best Perro Podcasts (2022) - Player FM

... हिन्दी, বাংলা, ไทย, ქართული, 中文, 日本語, 한국어 ... How The Orphan Drug System Has Been Gamed By Drug Companies - by Gerald Posner ...

#89. Grifols employee portal

Just click here and enter your zipcode Grifols has dozens of drugs in ... an orphan lung disease company, announced the company has entered into an ...

#90. Regulatory framework for the treatment of orphan diseases

Among the major pharmaceutical markets, the European Union has most recently enacted orphan drug legislation, ...

#91. Source Book of Statistics of Income: Active corporation ...

83 ORPHAN DRUG CREDIT . ... 并我其是我是中中 44 中文本求中本中中中求求中求求求求求求中中中*** ***长兴县**中中來本* 134 * 51678 * 23414 * 15858 * 611 * 287 ...

#92. Ning wang Zhu Quan ji qi Geng xin yu ce / He Bingyu, Zhao ...

香港 : 香港大學中文系 ; [Australia] : School of Modern Asian Studies, Griffith University, 1983. Physical Description. 3, 78 p. ; 22 cm.

#93. Columbus Metropolitan Library

Columbus Metropolitan Library offers helpful services and resources to the Columbus, Ohio community. Browse our library, find information, and access our ...

#94. EvaluatePharma Orphan Drug Report 2020

The Past, Present and Future of Orphan Drugs. Four decades ago, patients with rare diseases had very few treatment options. The 1983 Orphan Drug Act changed ...