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, ...
ZonesIIIandIV在气候带III和IV，药物注册申请所提供的稳定性数据 Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts 1、DrugSubstance2、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。Drug...
ZonesIIIandIV在气候带III和IV，药物注册申请所提供的稳定性数据 Q1A(R2)StabilityTestingofNewDrugSubstancesandProducts 1、DrugSubstance2、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。Drug...
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 ...
Cost-effective ICH stability testing from GMP facilities supporting new drug development covering all ICH climatic zones and bespoke conditions.
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...
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DataStatus:Step 5 稳定性数据的评估 Q1F Stability Data Package for Registration Applications in Climatic Zones III and IVStatus: Withdrawn 在气候带III和IV,药物注册申请所提供的稳定性数据 Comments:Q1A到Q1E共计5个指南,均...
5、: 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8. Q2: Analytical Validation分析验证 9. Q2(R1): Validation of Analytical Procedures: 6、0;Text and Methodology 分析程序的验证:正文及方法论 10. Q3: Impurities ...
Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug 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 在气候带III和IV,药物注册...