查询词典 Investigational

7 Accountability procedures for the investigational product, including the placebo and comparator, if any.

6.4.7 研究产品的责任程序，包括安慰剂和比较剂，如果有的话。

Chariman Fitzsimmons indicated that the company will not pursue a full-scale launch of the TFAS in Europe at this time."Initially, our plan is to take a careful, investigational approach with a few prominent centers and accumulate clinical experience with the device."

Fitzsimmons主席指出：此时公司不会在欧洲全力推广应用，"我们的最初的计划是与一些著名的中心采取细致的、探索性途径来积累这种设备的临床应用经验。"

Lonsdale Investigational New Drug approval for the investigational use of oral TTFD.

法律地位： TTFD 还没有得到 FDA 批准。医生也许会将其使用在单个病人的复合用药上。

Nucleonics, Inc., a biotechnology company focused on the development of novel expressed interfering RNA based therapeutics, announced today that it has received clearance from the US Food and Drug Administration for its Investigational New Drug application to begin a Phase 1 human safety study of Nucleonics' investigational eiRNA therapy for the treatment of chronic hepatitis B infection.

nucleonics公司，该公司是一家生物技术公司，专注于开发新型表达干扰核糖核酸方法根据疗法今天宣布，它已收到了手续，由美国食品和药物管理局，其在研新药应用展开第一阶段人体安全性研究nucleonics的侦查eirna疗法治疗慢性肝炎乙感染。

Procedures describing OOT limits, responsibilities for all aspects of an OOT system, and investigational directions are all components of a company's quality system.

描述OOT限度，OOT系统各个方面的职责以及调查方向的程序是一个公司质量系统的组成部分。

A description should be provided of the investigational product substance including the chemical and/or structural formula(e, and a brief summary should be given of the relevant physical, chemical, and pharmaceutical properties.

应该提供产品描述，并提供相关物理，化学和药学特征的简短总结。

May 6, 2004 In surgically menopausal women with hypoactive sexual desire disorder, treatment with an investigational transdermal patch was associated with significant increases in sexual desire and sexual activity with no serious adverse effects, according to findings reported here at the 52nd annual clinical meeting of the American College of Obstetricians and Gynecologists.

May 6， 2004 --根据在第52届美国妇产科年度临床会议中发表的研究发现，经外科手术停经且有性欲减低疾病hypoactive sexual desire disorder (HSDD的妇女，在施予研究性经皮肤渗透方式给予睾固酮的治疗后，妇女的性欲与性活力明显地增加，并且无严重副作用的产生。

May 6, 2004 In surgically menopausal women with hypoactive sexual desire disorder, treatment with an investigational transdermal patch was associated with significant increases in sexual desire and sexual activity with no serious adverse effects, according to findings reported here at the 52nd annual clinical meeting of the American College of Obstetricians and Gynecologists.

May 6， 2004 --根据在第52届美国妇产科年度临床会议中发表的研究发现，经外科手术停经且有性欲减低疾病hypoactive sexual desire disorder (HSDD的妇女，在施予研究性经皮肤渗透方式给予睪固酮的治疗后，妇女的性欲与性活力明显地增加，并且无严重副作用的产生。

1 Name and description of the investigational product.

6.2.1 研究产品的名称和描述。

Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the Investigational device exemption regulations under 21 CFR, Part 812, All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards and the Food and Drug Administration prior to conduct of the investigation.

任何用此装置来固定/连接腰椎，胸椎，和腰椎间的螺丝，将被视为是研究试验，并且视为极其危险装置的研究试验。按照联邦法规全书21章第812条关于研究性装置免责条款所规定，所有螺丝固定/连接装置的用户在接受研究试验前，必须得到他们各自机构的研究委员会的批准和&食品和药品管理局&的批准。

And Pharaoh spoke to Joseph, saying, Your father and your brothers have come to you.

47：5 法老对约瑟说，你父亲和你弟兄们到你这里来了。

Additionally, the approximate flattening of surface strip using lines linking midpoints on perpendicular lines between geodesic curves and the unconditional extreme value method are discussed.

提出了用测地线方程、曲面上两点间短程线来计算膜结构曲面测地线的方法，同时，采用测地线间垂线的中点连线和用无约束极值法进行空间条状曲面近似展开的分析。