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

#11. surrogate endpoint翻譯及用法- 英漢詞典 - 漢語網

surrogate endpoint中文 的意思、翻譯及用法：替代終點。英漢詞典提供【surrogate endpoint】的詳盡中文翻譯、用法、例句等.

#12. 中英名詞對照表

英文, 中文. active control, 有效藥對照組. adverse events, 不良事件 ... primary endpoint, 主要指標. probably, 很可能 ... surrogate endpoint, 替代指標.

#13. 博客來-Surrogate Endpoints in Medicine

書名：Surrogate Endpoints in Medicine，語言：英文，ISBN：9781586032470，頁數：66，作者：Wagner, J. A. (EDT)，出版日期：2002/05/01，類別：自然科普.

#14. 314.510 - CFR - Code of Federal Regulations Title 21 - FDA

314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

#15. Utilization of treatment effect on a surrogate endpoint ... - X-MOL

To design a phase III study with a final endpoint and calculate the required sample size for the desired probability of success, ...

#16. ENDPOINT在劍橋英語詞典中的解釋及翻譯

In addition, they usually use results based on surrogate or intermediate endpoints to obtain the final endpoints. 來自Cambridge English Corpus. We found general ...

#17. 問答集統計觀點 - 台灣臨床試驗資訊平台

使用替代性指標（surrogate endpoint）的適當性。以替代性指標為主要評估指標，必須是已被大家認定且廣為接受之指標。例如癌症治療之確認性試驗（confirmatory ...

#18. 統計學研究所- 碩士論文 - 國立交通大學機構典藏

中文 摘要. 醫藥研發是非常具有風險、複雜、高成本又費時的過程。 ... well-established and well-understood endpoints or surrogate marker when executing.

#19. endpoint | English to Chinese | Medical: Health Care - ProZ.com

其它相关概念，clinical endpoint（临床终点）, surrogate endpoint（替代 ... clinical endpoint是什么意思_clinical endpoint中文翻译是:临床终点.

#20. endpoint – 中文翻译

endpoint ['εndpɔɪnt] 名词 ... Common endpoints include severe toxicity, disease progression, and death. 亦见clinical trial, surrogate endpoint ...

#21. 序号英文原文中文翻译1 Accumulation of the parent drug and ...

中文 翻译. 1. Accumulation of the parent drug and its metabolite. 母体药物和代谢物的蓄积 ... Clinical endpoint. 临床终点 ... Surrogate endpoint. 替代终点.

#22. 病人、藥廠雙贏/ 雙輸？FDA 藥物加速審查制度持續面臨挑戰

1. https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure

#23. surrogate endpoint 的中文含义- dute.org

单词surrogate endpoint 的含义：[0] 替代终点. ... 本工具支持查询英文和中文单词及词组的含义，查询效率高、结果丰富，包括单词变体、常用短语、英英释义、同义词、 ...

#24. Surrogate endpoint - Wikipedia

In clinical trials, a surrogate endpoint (or surrogate marker) is a measure of effect of a specific treatment that may correlate with a real clinical ...

#25. 疫苗的臨床療效指標與免疫橋接在疫苗研發的角色

Efficacy Endpoints and the Role of Immuno-Bridging in Vaccine Development. 徐麗娟(Lih-Jiuan Hsu ). 台灣醫學; 27卷2期(2023 / 03 / 25) , P206 - 210. 繁體中文 ...

#26. Evaluating Clinical Efficacy of Antiviral Therapy for COVID-19

Evaluating Clinical Efficacy of Antiviral Therapy for COVID-19: A Surrogate Endpoint Approach. Hsiao Hsuan Jen, Wei Jung Chang, Ting Yu Lin, Chen Yang Hsu, ...

#27. FDA Pulls Back the Veil on Surrogate Endpoints | Wilson Sonsini

A possible example of a surrogate endpoint is tumor shrinkage after administration of an anti-cancer drug candidate. The shrunken tumor would ...

#28. 临床试验的结局和终点 - 百度文库

End event和endpoint翻译时可能会造成混淆。 进一步阅读： 1. Considerations in the Evaluation of Surrogate Endpoints in Clinical Trials: Summary of ps.也有人将终点 ...

#29. Progression-free survival as a surrogate endpoint of overall ...

Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic colorectal cancer Giuseppe Cicero,1 ...

#30. 運用多階段隨機過程模式於抗病毒藥物臨床效益評估

Evaluating Clinical Efficacy of Antiviral Therapy for COVID-19: A Surrogate Endpoint Approach. Infectious diseases and therapy, 1-11.)

#31. a New Surrogate Endpoint in Rectal Cancer Clinical Trials

The conduct of clinical trials in colorectal cancer has historically relied upon endpoints such as disease-free (DFS) or overall survival (OS).

#32. 藥品臨床試驗報告之格式及內容基準

英文, 中文. active control, 有效藥對照組. adverse events, 不良事件 ... primary endpoint, 主要指標. probably, 很可能 ... surrogate endpoint, 替代指標.

#33. <已截止>2022/6/11 (星期六)【新藥開發系列】 Strategies for ...

Endpoint for clinical trial (臨床指標) 2. Biomarkers (生物標記) – Surrogate endpoints, prognostic markers and predictive markers ...

#34. NHRI Communications

疫苗的臨床療效指標（clinical endpoint）應該預先定義；若是選用替代性療效指標（surrogate endpoint），則要確認指標資料的可行性（feasibility）與有效 ...

#35. 乳癌先導性治療的新思維

(surrogate endpoint)？ 前面提過的NSABP B-18試驗，接受先導性化學. 治療的病人，若能達到病理完全緩解(pCR)則無疾病. 存活期和整體存活期都會比沒有達到病理完全緩解 ...

#36. 多重解析地址选择页面 - 中文DOI

Title：, Magnetic resonance imaging-proton density fat fraction:A potential surrogate endpoint for nonalcoholic steatohepa-titis clinical trials.

#37. 臨床試驗與個人化醫療研究Clinical Trials and Personalized ...

Improper definition of the endpoint for variable length of follow-up entailed ... experimental drugs and the use of “surrogate endpoints”.

#38. 卵巢癌的研究，PFS與我們想看的OS (overall survival) 關係最 ...

... survival) 是癌症研究中常使用的臨床終點(clinical endpoint)，但. ... 是一種代理終點(surrogate endpoint)，但不一定是個好的代理終點～

#39. 藥品臨床試驗報告之格式及內容基準

中文 active control. 有效藥對照組 adverse events. 不良事件 antibody level. 抗體濃度 ... primary endpoint. 主要指標 probably ... surrogate endpoint. 替代指標.

#40. surrogate - WordReference.com 英汉词典

surrogate - WordReference.com 英汉词典. ... 英语, 中文 ... parent], surrogate pregnancy, a surrogate [marker, indicator, measure, endpoint], 更多…

#41. 人工關節MITOCELL IM科專計劃書surrogate endpoints替代性 ...

生物标记物如何成为新药申请的临床替代终点（Surrogate endpoints），加速新药临床研究的进程，这将是Biomarker技术研究面临的… blog.sciencenet.cn|.

#42. Table of Surrogate Endpoints That Were the Basis of Drug ...

'' This surrogate endpoint table includes surrogate endpoints that sponsors have used as primary efficacy clinical trial endpoints for approval ...

#43. Accelerating – and maintaining – drug approvals in the U.S.

The primary efficacy endpoint was complete remission. ... These surrogate endpoints, the FDA stated, can also support regular approval ...

#44. Hannah Ensor - Statistician - Edinburgh Clinical Trials Unit

Surrogate endpoints that can be used to predict treatment effect on an unobserved true endpoint are valued as their employment may reduce the length, ...

#45. IQWiG Issues Final Report on Handling of Surrogate ...

IQWiG Issues Final Report on Handling of Surrogate Endpoints in Benefit Assessments of Cancer Drugs. Published: 17 May 2011 The objective of the Institute ...

#46. CLINICAL ENDPOINTS 中文是什么意思- 中文翻译 - Tr-ex

犹他大学，NicholasJohnson，强直性肌营养不良1型的前瞻性研究，以确定生物标志物和临床终点，5年内资助大约200万美元。 An effect on a surrogate endpoint or on an ...

#47. US: Accelerated approval trials: Commenters seek details on ...

Commenters also called on the agency to provide more specifics on surrogate endpoints and the use of real-world data and evidence.

#48. FDA發佈臨床試驗終點（endpoint）相關指南

來源：生策會編譯美國食品和藥物管理局（FDA）上週發佈指南（guidelines），釐清評估候選.

#49. Jun (Vivien) Yin, Ph.D. - Mayo Clinic Faculty Profiles

The primary research interests of Jun (Vivien) Yin, Ph.D., are dose-finding trial designs, basket and umbrella trial designs, surrogate endpoint evaluation, ...

#50. The Evaluation of Surrogate Endpoints

同济大学图书馆书目检索系统. Online Public Access Catalogue. 中文, English. | 暂存书架(0) | 登录.

#51. Exam 3: Endpoints Flashcards | Quizlet

What is DOE? Disease Oriented Evidence (or outcomes) (1) Outcomes of studies that measure physiologic or surrogate markers of health

#52. A Click-and-Release Pyrrolysine Analogue - 首頁

Statistical Validation of Endophenotypes Using a Surrogate Endpoint Analytic Analogue 國立交通大學 Huang, Guan-Hua; Hsieh, Chin-Chiang; Chen, Chen-Hsin; ...

#53. 2022surrogate中文-遊戲直撥體驗攻略影片，精選在Youtube上 ...

surrogate中文相關搜尋相關結果都幫你找好了 ... FDA 於日前（7/23）公布替代性指標清單（Surrogate Endpoint Table），該表係建立在21 世紀醫療 ...

#54. How to use frailtypack for validating failure-time surrogate ...

Thus, a validated surrogate endpoint from meta-analytic data can be used to predict the treatment effect upon the true endpoint in any trial. In the meta- ...

#55. Introduction to Interim Analyses (中期分析) | 學術寫作例句辭典

The meta-analysis demonstrated that rPFS might serve as a potential surrogate endpoint of OS and offer opportunity to facilitate the interim analyses and ...

#56. DataContract Surrogate - WCF - Microsoft Learn

但實際上是使用資料合約Surrogate 來達成這項取代。 ... description, ServiceEndpoint endpoint, System.ServiceModel.Dispatcher.

#57. Withdrawing Approval of Makena — A Proposal from the FDA ...

Chinese Translation 中文翻译 ... Trial 003 did not demonstrate an effect of Makena on the surrogate end point of preterm birth, ...

#58. 枳实饮｜治疗阿尔兹海默症的新药获批的争议焦点到底是什么？

... 中文名：阿杜卡玛单抗）用于治疗阿尔兹海默症（Alzheimer's disease， ... 的替代终点（Surrogate endpoint），FDA是否因此降低了通过标准？

#59. 利妥昔单抗免疫化疗时代弥漫大B 细胞淋巴瘤替代终点研究

free survival (EFS) or progression-free survival (PFS) as the surrogate endpoint of OS can help to identify treatment benefit earlier, reduce ineffective ...

#60. Assessment of Progression-Free Survival as a Surrogate End ...

Key Points español 中文 (chinese). Question Is progression-free survival a validated surrogate end point for overall survival in first-line ...

#61. Clinically meaningful 释义| 柯林斯英语词典

Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. Retrieved from Wikipedia CC BY-SA ...

#62. Disease-free survival as a surrogate for overall survival in ...

We hypothesized that disease-free survival (DFS) could be a surrogate endpoint for OS in upper tract urothelial carcinoma (UTUC) patients treated with ...

#63. Rationale for intensive statin treatment in high-risk patients

Results of recent clinical and surrogate end point trials confirm that intensive lowering of low-density lipoprotein cholesterol is beneficial and safe in a ...

#64. NEJM医学前沿

... 期刊荟萃》独家授权在中国地区以数字媒体形式出版其发表原文的中文译著。 ... approvals based on a surrogate endpoint as of December 31, ...

#65. 《附新藥收載申請書》

藥品名稱, 中文 ... 比較之成本效益分析結果，並優先選擇採用實際最終療效結果(final outcomes)的研究，其次才考慮參照使用替代療效指標(surrogate endpoint)的研究。

#66. FDA Accelerated Approval

By evaluating a surrogate endpoint that is reasonably likely to predict clinical benefit, the AA pathway allows patients to access treatments at the earliest ...

#67. 血管張力素-醛固酮系統阻斷劑在心血管及腎臟疾病的角色

分的替代終點(surrogate endpoint)，如左心至肥 ... For Endpoint reduction in hypertension study (LIFE): ... surrogate endpoints and dual RAS blockade.

#68. 黃冠華| 國立陽明交通大學統計學研究所

繁體中文; English ... 2009, Huang GH*, Hsieh CC, Chen CH, Chen WJ, Statistical validation of endophenotypes using a surrogate endpoint analytic analogue, ...

#69. 美国FDA加速审批的药物无临床效果，且长期未被取消上市资格

英国医学杂志中文版,2021, 24 (11): 625-627. ... and biologic accelerated approvals based on a surrogate endpoint as of December 31, 2020.

#70. Drug Shown To Significantly Improve Survival In Men With ...

Surrogate endpoints are biomarkers that can be “substituted” or used in place of a clinical endpoint. “A critical goal of our research is to ...

#71. 醫藥品專利權期間延長 國內外法制與爭議案例比較研究

和中文標籤、原文和中文仿單及樣品，並繳納費用，申請中央衛生主管機關查 ... Surrogate Endpoint Resources for Drug and Biologic Development. Retrieved from.

#72. Senior Director Market Access Analytics & RWE

Analyses of key endpoints including surrogate endpoint validation; Comparative effectiveness research using (network) meta analyses and ...

#73. 美国食品药品监督管理局（FDA）肝病学与营养学部关于非酒精 ...

Accelerated approval relies on adequate and well-controlled clinical trials establishing that the drug affects a surrogate endpoint that is ...

#74. 临床试验的统计原则E9

The primary variable („target‟ variable, primary endpoint) should be ... efficacy is not practical, indirect criteria (surrogate variables ...

#75. Error "COM Surrogate has Stopped Working" After installation ...

in Notification Action, Traps will not blocking the endpoint, and on security event i dont see prevention from exploit for this PC. Why this ...

#76. Biomarker assays: Bioanalytical meets CLIA - ICON plc

While they are not true indicators of how well a therapy will work, the use of biomarkers as surrogate endpoints in clinical trials is critical ...

#77. Retrophin Provides Sparsentan Regulatory Update

Notably, the trial will include an interim analysis of proteinuria as a surrogate endpoint to serve as the basis for an NDA filing for ...

#78. U.S. Food and Drug Administration (FDA) Accepts Mirati ...

... which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint.

#79. 實證看待Ivabradine於心肌梗塞之安全性 - 藥學雜誌電子報145期

在左心室射出分率(LV ejection fraction)改善的部分，ivabradine明顯優於bisoporol (p=0.04) 11 。 上述研究僅限於替代終點(surrogate endpoint)觀察，然而 ...

#80. 期刊界All Journals 搜尽天下杂志传播学术成果专业期刊搜索 ...

There is increased interest in surrogate endpoints for clinical trials of chronic kidney disease. Methods. In this nationwide observational study of 456 ...

#81. 第54屆藥物資訊年會(DIA)及TFDA藥政專題論壇

in Drug Development for Binary Endpoints」為題投稿大會專題海報，或邀請於海 ... Surrogate endpoint (blood Phenylalanine (Phe) level).

#82. 晚期结直肠癌疗效评价标准的研究进展

Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based ... 大肠癌患者生命质量测定量表FACT-C(V4.0)中文版应用评价.

#83. Scientific Misconduct Check (PDF)

"Design and Endpoints of Clinical Trials in Hep. ... 翻译成中文. 关闭取词 ... [PDF] Objective response rate is a possible surrogate endpoint.

#84. 新药从研发到上市的全流程：IND、NDA、ANDA傻傻分不清

... 的“替代终点”（Surrogate endpoint），即药物预期的治疗效果的指标， ... 另外，ANDA的英文全称为Abbreviated New Drug Application，中文称为仿 ...

#85. March 2015 - On Biostatistics and Clinical Trials

Chinese (中文). Active Control ... Endpoint Assessment or Adjudication Committee (EAC) ... Surrogate Endpoint and Surrogate Variable.

#86. 赵海潞博士-糖尿病系统医学研究中心

2006——2010年香港中文大学医学院内科药物与治疗学系、香港糖尿病与肥胖研究 ... in albuminuria as a surrogate endpoint in chronic kidney disease.

#87. Medical University of Bialystok. Hasselt University (UHasselt ...

... topics as statistical modelling of complex data, surrogate endpoint validation, or modelling microarray data in early drug development.

#88. 真實世界研究與臨床試驗（二、輔助篇） - 林星帆顧問

在不夠長的追蹤時間之下，常常來不及觀察到興趣事件的發生，例如急性心肌梗塞、急性缺血性中風等，而只能使用替代性終點（surrogate endpoint）或組合 ...

#89. [EBM] 如何以CASP評讀工具來評讀RCT - Med Data Speaks

... 以關鍵字搜尋"intention"，此範例：The coprimary efficacy endpoints ... 降低血糖、降低糖化血色素(HbA1c)，這些都是surrogate endpoint (代理 ...

#90. end point - Sesli Sözlük

end point çevirisi anlamı nedir nasıl telaffuz ediliz. ... efficacy, or other objective of a trial See also Surrogate Marker Source: Applied Clinical ...

#91. Clinical Development 301: Phase II/III - BioTechPrimer

Regulatory significance of clinical endpoint, primary endpoint, secondary endpoint, surrogate endpoint. Fluency in Phase II and Phase III clinical trial nuances ...

#92. EBM Focus: Nonfatal Myocardial Infarction (MI) — Death of a ...

Establishing that one endpoint can serve as a surrogate, i.e., can substitute for another, requires a higher level of “proof” and nonfatal MI ...

#93. Aducanumab Approved for Treatment of Alzheimer's Disease

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Drug companies are still required to ...

#94. Minimal residual disease: the defining moment we have all ...

Through advancing science and adopting MRD as a surrogate endpoint in research, we can offer real hope to patients too, by potentially reshaping the myeloma ...

#95. CRO Perspectives: Driving Innovation, Consistency and ...

... moving from exploratory use to primary and secondary endpoints. ... as a surrogate endpoint for regulatory approval. 16 Going forward, ...

#96. Definition of surrogate endpoint - National Cancer Institute

Surrogate endpoints include a shrinking tumor or lower biomarker levels. They may be used instead of stronger indicators, such as longer survival or ...

#97. 抗腫瘤藥物臨床試驗－常見的療效終點(Endpoints) - 暘氏手札

對於從事癌症臨床試驗的研究人員，想必對其它像是OS、PFS、DFS、TTP等「臨床試驗終點(Clinical Trial Endpoints)」的研究指標並不陌生。