首页> Biologicals : journal of the International Association of Biological Standardization> Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

导出 LinkOut

翻译打印收藏纠错

第一作者： Binbing,Yu

第一单位： MedImmune LLC, Gaithersburg, MD 20878, United States. Electronic address: yub@medimmune.com.

作者： Binbing,Yu ^[1] ; Lingmin,Zeng ^[2] ; Harry,Yang ^[2]

作者单位： MedImmune LLC, Gaithersburg, MD 20878, United States. Electronic address: yub@medimmune.com. ^[1] MedImmune LLC, Gaithersburg, MD 20878, United States. ^[2]

关键词 Accelerated stability study Acceptance criteria Process comparability Sample size

医学主题词生物制品(Biological Products);药物稳定性(Drug Stability);模型, 化学(Models, Chemical)

DOI 10.1016/j.biologicals.2017.07.001

PMID 28743417

发布时间 2018-05-14

翻译满意度评价：

准确一般字义偏差语意偏离译文作用小提交

浏览4

Biologicals

2017年49卷

46-50页

相似文献

中文期刊
外文期刊
学位论文
会议论文

浏览4

点击下载本期目录封面

Biologicals

2017年49卷

46-50页

检索历史清除

Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

Biologicals

相似文献

同项目论文

Biologicals

相关期刊

参考文献：
指定格式：	NoteExpress EndNote RefWorks NoteFirst

检索历史 清除

Determination of acceptance criteria and sample sizes for accelerated stability comparability studies for biologics.

Biologicals

相似文献

同项目论文

Biologicals

相关期刊

检索历史清除