参考文献: [1].Chavda H. In-use stability studies: guidelines and challenges. Drug Dev Ind Pharm. 2021 Sep;47(9):1373-1391. [2].Blümel M, Liu J, de Jong I, Weiser S, Fast J, Litowski J, Shuman M, Mehta SB, Amery L, Tan DCT, Jia F, Shekhawat D, Dagallier C, Emamzadeh ...
In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products,2020指出对于人用多剂量注射剂,有体积30ml、使用期限28天限制,或者可以进行支持性研究,在标签上可标注其他期限。 NMPA2020版中国药典通则9001《原料药物与制剂稳定性试验指导原则》有些药物制剂还应考察临用...
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 studies: guidelines and challenges https://doi.org/10.1080/03639045.2021.1994991 ...
The purpose of this review was to identify trends in the study of in-use stability of nonsterile dosage forms and to present specific considerations necessary for conducting in-use stability tests.Area covered In this paper, in-use stability studies of nonaqueous and water-containing, nonsterile...
In-use stability studies: guidelines and challenges https://doi.org/10.1080/03639045.2021.1994991 ...
Inusestability专题研究 第01章:inusestability概念解析 Inusestability,顾名思义,指的是药品使用期间稳 定性研究项目。 对于如下使用条件的药品,需要考察inusestability 项目: ---药品使用前,需要重新配置或者稀释; ---药品标签声明,和其他药品混合仍然具有稳定性; ...
In-use stability studies: guidelines and challenges 2021, Drug Development and Industrial Pharmacy Patient safety: Key driver to preservative-free nasal spray development 2019, ONdrugDelivery Sodium perbarate and benzalkonium chloride induce DNA damage in Chang conjunctival epithelial cells 2017, Cutaneous...
Prior to administration,atezolizumab is diluted in normal saline (0.9% sodiumchloride) in polyvinylchloride or polyolefin infusion bags.The objective of the studies reported in this paper was toevaluate the stability of atezolizumab diluted to 2.4 mg/mLand 9.6 mg/mL (Study 1), and 16.8 mg/mL...
There is widespread concern that the rising unemployment may pose(构成) a threat to social stability. 人们普遍担心,不断上升的失业率可能对社会稳定构成威胁。 After a(n) comprehensive(全面的) physical exam, my doctor said I was in good condition except that my blood pressure was a little high....