ICH：Quality质量
Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)
新原料药和制剂的稳定性试验（第二版）
Q1B: Photostability Testing of New Drug Substances and Products
新原料药和制剂的光稳定性试验
Q1C: Stability Testing for New Dosage Forms
新制剂的稳定性试验
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
对稳定性数据的评估处理
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
Q2A: Text on Validation of Analytical Procedures
分析程序的验证
Q2B: Validation of Analytical Procedures: Methodology
分析程序的验证：方法学
Q3A(R): Impurities in New Drug Substances (Revid Guideline)
新原料药中的杂质（修订版）
Q3B(R): Impurities in New Drug Products (Revid Guideline)
新制剂中的杂质（修订版）
Q3C: Impurities: Guideline for Residual Solvents
杂质：残留溶剂指南
Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)
杂质：残留溶剂指南（修改内容）
Q4: Pharmacopoeias药典
Q4A: Pharmacopoeial Harmonisation 药典的协调
Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability
药典互替在法规上的可接受性
Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
来源于人或者动物细胞系的生物技术产品的病毒安全性评估
Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Ud for Production of r-DNA Derived Protein Products
生物技术产品的质量：源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析
Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
生物技术产品的质量：生物技术/生物产品的稳定性试验哈尔滨新东方
Q5D: Derivation and Characterisation of Cell Substrates Ud for Production of Biotechnological/Biological Products
用于生产生物技术/生物产品的细胞底物的起源和特征描述comac
Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
基于不同生产工艺的生物技术产品/生物产品的可比较性
Q6: Specifications for New Drug Substances and Products
新原料药和制剂的质量规格
Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
质量规格：新原料药和新制剂的检验程序和可接收标准：化学物质
Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products滞留是什么意思
质量规格：生物技术/生物产品的检验程序和可接收标准老友记中英文字幕在线观看
mers怎么读
Q7: Good Manufacturing Practices for Pharmaceutical Ingredients
活性药物成份的GMP
3839Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
活性药物成份的GMP指南
Q8: Pharmaceutical Development
药物研发
Q9: Quality Risk Management
质量风险管理
ICH：Safety安全
S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
药物致癌性研究需要的指南
S1B: Testing for Carcinogenicity of Pharmaceuticals
药物致癌性的检验
S1C: Do Selection for Carcinogenicity Studies of Pharmaceuticals
药物致癌性研究之剂量选择
S1C(R): Addendum: Addition of a Limit Do and Related Notes
附录：极限剂量和有关注释的的补充
S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
受法规管辖的药物基因毒性检验的特定方面的指南
S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals
基因毒性：药物基因毒性检验的标准
S3A: Note for Guidance on Toxicokinetics: The Asssment of Systemic Exposure in Toxicity Studies
毒物代谢动力学指南的注释：毒性研究中的全身性暴露量的评估
S3B: Pharmacokinetics: Guidance for Repeated Do Tissue Distribution Studies
药物代谢动力学：重复剂量的组织分布研究指南
S4: Single Do Toxicity Tests
单剂量毒性检验
S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)
动物体内慢性毒性持续时间的检验（啮齿动物和非啮齿动物毒性检验）
S5A: Detection of Toxicity to Reproduction for Medicinal Products
药物对生殖发育的毒性的检验boat trip
S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Productsbreezy
对男性生殖能力的毒性的指南的变动：药物对生殖发育的毒性的检验指南增加了一个附录
S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
生物技术生产的药物的临床前安全评价
cleverbotS7A: Safety Pharmacology Studies for Human Pharmaceuticals
人用药的安全药理学研究
S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization
2020高考语文卷(QT Interval Prolongation) By Human Pharmaceuticals
药物延迟心室复极化（QT间期）潜在作用的非临床评价
S8: Immunotoxicology Studies for Human Pharmaceuticals
人用药免疫毒理学研究
M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
