In the complete response letter there are no requests for new pre-clinical or clinical trials.
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。
She achieved a complete response and remains relapse-free 21months after her last dose of chemotherapy. Conclusion.
患者获得了完全缓解并在末次化疗后的21个月持续无复发。
Results:In study group, after neoadjuvant chemotherapy, 9 cases achieved clinical complete response (CR) and 37 cases achieved partial response (PR).
结果:新辅助化疗后,观察组术前肿瘤病灶临床完全缓解(CR)9例,部分缓解(PR)37例。
The results also indicate that a complete response to neoadjuvant endocrine therapy is rare compared to neoadjuvant chemotherapy.
这项研究结果也显示,相比较新辅助化疗,罕见对新辅助内分泌治疗有完全的缓解。
The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility.
该完整回复函并不包括2009年12月FDA对俄亥俄州生产车间的批准前现场核查有关的要求。
Using time-frequency-and complex frequency domain analysis to find the complete response of the circuit from the different point, has the different physics meaning and calculating method.
电路的时域、频域和复频域三种分析法求解电路的完全响应,比较了三种分析法的物理意义和计算方法。
Results: of 33 evaluated patients, a 70% overall response rate (complete response plus complete response unconfirmed, 45%) and a median progression-free survival (PFS) of 16.5 months were achieved.
结果:在33个被评估的病人中,总的反应率为70%(完全反应率加未确定的完全反应率,45%),中位无进展生存期为16.5个月。
Complete response rates were similar for children with either mutation and children with wild-type FLT3, the authors report.
作者报道,有突变患儿和野生型FLT3患儿的完全有效率是相似的。
Complete response rates were similar for children with either mutation and children with wild-type FLT3, the authors report.
作者报道,有突变患儿和野生型FLT3患儿的完全有效率是相似的。
应用推荐