药物In-use stability testing或称为使用中稳定性试验,通过模拟产品实际使用场景,对关键指标如物理、化学、微生物学/生物学等参数进行研究,证明随着时间的推移,在温度、空气、光照、湿度等环境因素影响下,关键指标符合既定质量标准,从而确定使用中存储条件、期限等,目的是为如多剂量药物开启后存储条件、使用期限,或临床...
··前言药物In-use stability testing或称为使用中稳定性试验,通过模拟产品实际使用场景,对关键指标如物理、化学、微生物学/生物学等参数进行研究,证明随着时间的推移,在温度、空气、光照、湿度等环境因素影响下,关键指标符合既定质量标准,从而确定使用中存储条件、...
生物大分子注射剂使用中(In-use)稳定性设计考虑 使用中稳定性研究目的是考察药物在临床配制、存放和使用过程中质量随时间的变化情况,为注射剂药品的配制、配制后药液的存放条件和允许时限等提供依据。相比于小分子化药,配伍后的大分子注射剂物理化学性质可能更不稳定性,与配伍的容器发生不相容的可能性更大。因此,在...
in use stability专题研究 In use stability专题研究 Zhulikou431 内部培训 2012 中国
in use stability专题研究 In use stability专题研究 Zhulikou431 内部培训 2012 中国
The use of liquid chromatography for purity and stability testing of bulk and formulated Pharmaceuticals is reviewed with particular regard to method devel... MW Dong,PV Passalacqua,DR Choudhury - 《Journal of Liquid Chromatography》 被引量: 20发表: 1990年 ...
The use of liquid chromatography for purity and stability testing of bulk and formulated Pharmaceuticals is reviewed with particular regard to method devel... MW Dong,PV Passalacqua,DR Choudhury - 《Journal of Liquid Chromatography》 被引量: 20发表: 1990年 ...
百度试题 结果1 题目 The test procedures used in stability testing should be___and be stability indicating. 相关知识点: 试题来源: 解析 validated 反馈 收藏
arena, however, Kirbyshire stresses that suitability for physical stability testing or large-molecule assessment is not currently proven. “With increased use of the technique,further advances will be made establishing ASAP as a reliable andcost-effective method of determining product stability,” he ...
arena, however, Kirbyshire stresses that suitability for physical stability testing or large-molecule assessment is not currently proven. “With increased use of the technique,further advances will be made establishing ASAP as a reliable andcost-effective method of determining product stability,” he ...