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...
[1] Lamanna WC, Heller K, Schneider D, et al. The in-use stability of the rituximab biosimilar Rixathon /Riximyo upon preparation for intravenous infusion.Journal of Oncology Pharmacy Practice. 2019;25(2):269-278. doi:10.1177/1078155217731506 [2] Ricci MS, Frazier M, Moore J, Cromwell ...
in use stability专题研究 In use stability专题研究 Zhulikou431 内部培训 2012 中国
微生物是确定储存条件和期限的一个重要因素。FDA及EMA相关法规均对临床药液配制及使用有严格要求。通常要求药液在4小时内药液配制和输液,如果规定在24小时内完成,则需要进行微生物挑战试验。 总结: 临床配伍相容性研究应按照以上方法分阶段进行,这有助于确定临床预期使用过程。在后续的验证性研究中,应充分模拟最差条件...
2001年3月,EMA发布了《NOTEFORGUIDANCEON IN-USESTABILITYTESTINGOFHUMAN MEDICINALPRODUCTS》,专门对此问题进行法 规阐述。 Inusestability专题研究 4.1-Objective 4.2-Scope 4.3-Introduction 4.4-Selectionofbatches 4.5-Testdesign 4.6-Teststorageconditions
The product was stored in different containers [polyolefin (PO) bags, glass bottles and syringes], and the protocol followed International Conference on Harmonisation (ICH) and European Medicines Agency (EMA) requirements for stability evaluation of biological products. Stability was evaluated using ...
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products." The guidance was prepared under the auspices o... H Fooddrug Administration - 《Fed Regis...
Development, Stability, and Sensory Testing of Microcapsules Containing Iron, Iodine, and Vitamin A for Use in Food Fortification Iodine, vitamin A, and iron deficiencies are important public health problems in developing countries and often coexist in vulnerable groups, such as pregn... R Wegmuller...
(Volpicelli and Fenton2006), but it was found to be less effective than the O’Neil implant (Reece2007). FDA-approved Probuphine, a long-acting buprenorphine implant by Titan Pharmaceuticals for individuals who have shown clinical stability for the buprenorphine trans-mucosal formulation (Rosenthal...
Yu H, Zhang Y, Xie Y, Wang Y, Duan L, Zhang M, Li Z (2017) Ethephon improved drought tolerance in maize seedlings by modulating cuticular wax biosynthesis and membrane stability. J Plant Physiol 214:123–133 CAS PubMed Google Scholar Yuan GF, Jia CG, Li Z, Sun B, Zhang LP, Liu...