ICHStabilityClimaticZones Countries of climatic zones I and II: Europe:EU, Belarus, Bulgaria, Estonia, Hungary, Latvia, Lithuania, Norway, Rumania, Russia, Switzerland, Ukraine America:USA, Argentina, Bolivia, Chile, Canada, Mexico, Peru, Uruguay Africa:Egypt, Algeria, Canary Islands, Libya, Moro...
ICH Stability Climatic Zones Countries of climatic zones I and II: Europe: EU, Belarus, Bulgaria, Estonia, Hungary, Latvia, Lithuania, Norway, Rumania, Russia, Switzerland, Ukraine America: USA, Argentina, Bolivia, Chile, Canada, Mexico, Peru, Uruguay Africa: Egypt, Algeria, Canary Islands, ...
Q1A (R2) Stability Testing of New Drug Substances and Products 新原料药和制剂的稳定性试验 Accelerated testing 加速试验 Bracketing 括号法 Climatic zones 气候带 Commitment batches 承诺批次 Container closure system 容器密封系统 Dosage form 剂型 Drug product 制剂 Drug substance 原料药 Excipient 辅料 ...
ICH指导原则Q1f Stability Data Package for Registration in Climatic Zones III and IV英文原版.pdf,INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE DRAFT CONSENSUS GUIDELINE STABILITY DATA
Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV 在气候带III和IV,药物注册申请所提供的稳定性数据 Q2(R1): Validation of Analytical Procedures: Text and Methodology 分析程序的验证:正文及方法论 Q3: Impurities杂质 Q3A(R2): Impurities in New Drug Substances 新原料...
iCH Q1F Guideline Stability Data Package for Registration in Climatic Zones III and IV Step 4 in the ICH process Comments for its application 文档格式: .pdf 文档大小: 89.37K 文档页数: 9页 顶/踩数: 0/0 收藏人数: 1 评论次数: 0
Q1E Evaluation of Stability DataStatus:Step 5 稳定性数据的评估 Q1F Stability Data Package for Registration Applications in Climatic Zones III and IVStatus: Withdrawn 在气候带III和IV,药物注册申请所提供的稳定性数据 Comments:Q1A到Q1E共计5个指南,均...
Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts 1、DrugSubstance 2、DrugProducts DrugSubstance StressTesting •强力破坏试验是通过建立降解途径，鉴定可能的降解产物，以确定分子的内在稳定性，并论证所使用的分析方法是否能反映产品的稳定性。DrugSubstance StressTesting •可以是单批原料药，包括温度（一般比...
3、e forms新剂型的稳定性试验q1d bracketing and matrixing designs for stability testing of new drug substances and products 原料药和制剂稳定性试验的交叉和矩阵设计q1e evaluation of stability data稳定性数据的评估q1f stability data package for registration applications in climatic zones iii and iv 在气候...
同时M又细分为5个小类M1:常用医学名词（MedDRA）M2:药政信息传递之电子标准M3:与临床试验相关的临床前研究时间的安排M4:常规技术文件(CTD)M5:药物词典的数据要素和标准 Q1A-Q1FSTABILITY稳定性 Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的稳定性试验Q1BStabilityTesting:PhotostabilityTestingof...