这将需要提出新的许可申请，包括开展新的生产验证研究，以及临床前和临床研究。
This would require a new licensing application, including conducting of new manufacturing validation studies; and pre-clinical and clinical studies.
在动物身上进行的临床前试验的结果鼓舞了研究人员，让他们有信心展开人体试验。
Preclinical tests in animals encouraged the researchers to be confident about starting human trials.
临床或临床前样品分析批汇总表。
Summary tables of analytical runs of clinical or preclinical samples.
临床或临床前分析批数据表。
Data tables from analytical runs of clinical or preclinical samples.
该临床前试验结果已经发表。
PPS紧密结合其它临床前的基础科学课程。
PPS is closely integrated with other preclinical "basic science" courses.
这个假设主要是基于临床前研究和流行病学研究的结果。
This assumption is mostly based on findings of preclinical studies and epidemiological research.
临床或临床前样品的再处理应仅根据预先确定的SOP进行。
Reintegration of a clinical or preclinical sample should be performed only under a predefined SOP.
一批新生血管抑制物正处于临床或临床前试验的研究阶段。
As potential anti tumor agents, a list of angiogenesis inhibitors are currently undergoing clinical and pre clinical study.
在该完整回复函中，FDA并未要求补充新的临床前或临床研究资料。
In the complete response letter there are no requests for new pre-clinical or clinical trials.
国内研究提示，NCTB可以用作噪声危害早期临床前损害的检测方法。
Domestic research prompts that NCTB can be used as the detective method for early clinical harm caused by noise.
在随机对照临床试验中并没有重现小规模临床前的调查中观察到的疗效。
To date, randomized, controlled clinical trials have not reproduced the efficacy observed in pre-clinical and small-scale clinical investigations.
目的评价在根管治疗术的临床前操作训练中树脂透明牙模型的作用和效果。
Objective to evaluate the validity of simulated resin transparent tooth models used in the pre-clinical practice training of root canal therapy.
另外还有临床前研究的资料证实这些药物对于蛋白尿也有一定的治疗效果。
There is also pre-clinical evidence of the favorable effect on proteinuria for example.
我们开发并描述了一个临床前的模型，用来评估免疫介导转移性乳腺癌疗法。
We have developed and characterized a preclinical model for the evaluation of immune-mediated metastatic breast cancer therapies.
也提到了21个后继项目处于各不同临床开发阶段，另47个处于临床前阶段。
It also says 21 further projects are at various stages of clinical development, with another 47 at the preclinical stage.
研究结论：(1)我国的临床前研究中引入项目管理，有助于管理质量的提高。
Conclusion: (1) Project management theories can improve the management level of the preclinical research of our country.
用户界面（60）将临床或者临床前显著性结果与相关联的置信区间一起显示。
A user interface (60) displays the clinically or preclinically significant result together with the associated confidence interval.
临床前研究和临床试验研究显示该药对多种肿瘤有抗肿瘤活性，不良反应较轻。
Preclinical researches and clinical trails show its anti-tumor activity with slight side effects.
在该系统应用于临床前，有必要对其进行理论建模、特性分析和模拟试验研究。
Before clinical application of the system, it is necessary to carry out theoretical modeling, performance analysis and simulated experimental study.
临床前阿尔茨海默病的推荐规范目的只是用于研究，并且在此时并没有临床实用性。
The recommendations of the preclinical Alzheimer's workgroup are intended for research purposes only, and do not have any clinical utility at this time.
当前的临床前和临床数据表明，与放疗结合的热疗技术是一种可行且有效的治疗方案。
The present preclinical and clinical data show that hyperthermia is feasible and effective in combination with radiation therapy.
强有力的临床前研究数据显示，食物过敏中药配方-2具有潜在治疗食物过敏的作用。
Strong preclinical study data suggest the potential efficacy of food allergy herbal formula-2 for food allergy.
尽管这一假说似乎容易证明，但却既没有临床前模型的证据，也没有来自患者的数据。
Although this hypothesis would seem readily testable, there is no evidence in pre-clinical models to support it, nor is there data from patients.
结论研制了高质量的冻干小鼠神经生长因子，为NGF的临床前和临床研究奠定了基础。
CONCLUSION High qualified lyophilized mouse nerve growth factor has been produced, which has laid a foundation for further NGF application research.
第二十三条药物临床前研究应当参照国家药品监督管理局发布的有关技术指导原则进行。
Article 23 Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SDA.
第二十三条药物临床前研究应当参照国家药品监督管理局发布的有关技术指导原则进行。
Article 23 Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SDA.
应用推荐