ICH指导原则目录.pdf,Quality Guidelines (质量) 编号 阶段 发布日期 内容 Q1 Stability (稳定性) Stability Testing of New Drug Substances and Q1A(R2) Step 5 2003-2-6 Products 新原料药和制剂的稳定性试验 Stability Testing : Photostability Testing of New Dru
Q1F: Stabilitiy Guidelines_WHO Q1F:WHO稳定性指导原则 2009 Q2 Analytical Validation/分析方法验证 Q2(R1): Validation of Analytical Procedures Text and Methodology Q2(R1): 分析过程和方法的确证 2005.11 Q3A - Q3D Impurities/杂质 Q3A(R2): Impurities in New Drug Substances Q3A(R2): 新型原料药中的杂...
Q1F: Stabilitiy Guidelines_WHO Q1F:WHO稳定性指导原则 2009 Q2 Analytical Validation/分析方法验证 Q2(R1): Validation of Analytical Procedures Text and Methodology Q2(R1): 分析过程和方法的确证 2005.11 Q3A - Q3D Impurities/杂质 Q3A(R2): Impurities in New Drug Substances Q3A(R2): 新型原料药中的...
International Conferences on Harmonization Q3A (R2). Draft Revised Guidance on Impurities in New Drug Substances, 2006.International Conference on Harmonization (ICH) (2007). The International Conference on Harmonization of Technical Requirements of Pharmaceut- icals for Human Use (ICH). Available at...
(R1): 分析过程和方法的确证 and Methodology Q3A(R2): 新型原料药中的 杂质问题 Q3B(R2): 新型药品中的杂 质问题 Q3C(R6): 残留溶剂的杂质指导 原则 阶段5 2005.11 Q3A(R2): Impurities in New Drug Substances Q3B(R2): Impurities in New Drug Products Q3A - Q3D Impurities Q3C(R6): Impurities ...
http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html这个链接可以查阅 我已经...
最新ICH指导原则_基础医学_医药卫生_专业资料。ICH Guidelines ICH Guidelines 说明 ICH的论题主要分为四类,因此ICH根据论题的类别不同而进行相应的编 码分类: 1. “Q”类论题:Q代表QUALITY,指那 ICH Guidelines ICH Guidelines 说明 ICH的论题主要分为四类,因此ICH根据论题的类别不同而进行相应的编 码分类: 1....
Q3A(R2): Impurities in New Drug SubstancesQ3A(R2):新原料药中的杂质阶段52006.10.25有 Q3B(R2): Impurities in New Drug ProductsQ3B(R2):新药制剂中的杂质阶段52006.6.2有 Q3C(R8) Impurities:Guideline for Residual SolventsQ3C(R8):杂质:残留溶剂的指导原则阶段52021.4.22有 ...
product containing a new solvent may be based on concepts in this guideline or the concept of qualification of impurities as expressed in the guideline for drug substance (Q3A, Impurities in New Drug Substances) or drug product (Q3B, Impurities in New Drug Products), or all three guidelines...
ICH Guidelines 王震 20150201 ICH Guidelines 说明 ICH的论题主要分为四类,因此ICH根据论题的类别不同而进行相应的编 码分类: 1. Q类论题:Q代表QUALITY,指那些与化工和医药,质量保证方面