Two critical questions one must answer as one applies the results of a clinical trial to clinical practice are: (1) Regardless of whether the trial result is likely to be replicated or reproduced in a second large-scale trial, are the results likely to be reproduced in one's practice? (2...
level and the sound pressure level of the direct sound for each doubling of the distance from the sound source. This translates to a 6 dB reduction in the sound intensity level and the sound pressure level of the direct sound for each doubling of the distance from the sound source.[...
aIf your system is managed by the Hardware Management Console (HMC), use the HMC to complete the steps for replacing the disk drive backplane in the server. For instructions, see 如果您的系统由硬件管理控制台(HMC)处理,使用HMC完成步为替换驱动器底板在服务器。 为指示,看见[translate] ...
clinical trials process on a timely basis or at all, whetherclinical trialresults will warrant submissionofapplicationsforregulatory approval, whether the Company will be able [...] businesswirechina.com businesswirechina.com 引起或造成这些差异的重要因素包括本公司能否获得监管部门对追加适应证的核准,本...
Procedures for the application for registration of foreign banks and other financial institutions shall be stipulated separately. 外资银行和其他金融机构的申请登记、注册手续另行规定。 en.pkulaw.cn 7. Article 25 For the application for registration of new drugs, clinical trial or bioequivalence trial sha...
for the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL).It is currently in Phase I clinical trial for r/r B-NHL. It was also granted ODD by the U.S. Food and Drug Administration in ...
This article is a response to the report of the Task Force on Promotion and Dissemination of Psychological Procedures of the Division of Clinical Psycholog... SL Garfield - 《Clinical Psychology Science & Practice》 被引量: 114发表: 1996年 Mipomersen and other therapies for the treatment of se...
clinical end point. Ultimately, fit-for-purpose requires an assessment of the technical ability of the assay to deliver against the predefined purpose. Abbreviations: IHC=immunohistochemistry; LBA=ligand binding assay; MS=mass spectrometry; PD=pharmacodynamic; POM=proof of mechanism; POC=proof of ...
3) clinical trial 临床试验 1. EMEA's consideration on strategy and design of clinical trials for new antibacterial agent; 欧盟医药管理局对新抗菌药物临床试验策略和设计的考虑 2. FDA's general considerations on the antibacterial dugs clinical trial protocol issues and its enlightenment; 美国FDA对...
CTA: clinical trial application;BE study: bioequivalence study;MRCTS: multi-regional clinical trials Legal Basis Drug Administration Law of the People’s Republic of China (2019 Revision); Regulations for the Implementation of the Drug Administration Law of the People...