美国仿制药申报要求和必威体育精装版案例分析-杂质课件.ppt

;FDA对药物杂质的控制要求：Contents 目录;Drug Production and Quality Control Synthesis of API;FDA对药物杂质的控制要求 原料药与成品药中的有机杂质;有机杂质来源;常见的降解反应;常见的降解反应;确定降解产物-强制降解研究（Forced Degradation Study);确定降解产物-原料药和制剂的稳定性试验;原料药与成品药中的有机杂质;Impurities: Origination Identification Classification of impurities;Impurities: Origination Identification Lists of Impurities in ICH;有机杂质控制限度设置;有机杂质控制限度设置;Control of Impurities: Compendia ICH Establishing Acceptance Criteria for Impurities;Control of Impurities: Compendia ICH  ICH Q3A(R) and Q3B(R). Scope;制剂的杂质限度Q3B(R2). ICH Threshold for Degradation Products in New Drug Products;有机杂质控制限度论证; 制订和论证杂质合理限度的决策树;有机杂质控制限度的论证方法;有机杂质控制限度的论证方法;有机杂质控制限度的论证方法;Impurity Limit Establishment: Examples Simvastatin Tablets USP. Limits for SV RCA and SV RCB;Impurity Limit Establishment: ExamplesBupropion ER Tablets: Justification for Increasing Limits;Impurity Limit Establishment: ExamplesSynthetic Impurities: No Need to Monitor/Report in DP Specifications;Impurity Limit Establishment: Examples Semi-Synthetic or Synthetic Chemical?;Impurity Limit Establishment: Examples Clyndamycin. Semi-synthetic or Synthetic Chemical?;案例分析：有机杂质控制限度设置和论证 卡托普利（Captopril) 原料药的合成路线;卡托普利（Captopril）有机杂质控制限度的设置;卡托普利（Captopril）有机杂质控制限度的设置;练习-杂质控制限度的设置和论证;练习-杂质控制限度的设置和论证;练习-杂质控制限度的设置和论证;FDA对药物杂质的控制要求 原料药与成品药中的残留溶剂;ICH Q3C and USP General Chapter 467;USP: Residual Solvents;Residual Solvents 467:Main Points;Residual Solvents 467:Main Points;Residual Solvents 467:Main Points, Continued…;Scope;Risk-based classification of solvents;Supplier;Supplier;Supplier;Supplier;Establishing Exposure Limits(Appendix 3 in the General Chapter);Limits of Residual Solvents;Limits of Residual Solvents: Class 1;Table 1. Class 1 Residual Solvents;Limits of Residual Solvents: Class 2;Table 2. Class 2 Residual Solvents;Table 2. Class 2 Residual Solvents Continued…;Table 2. Class 2 Residual Solvents Continued…;Limits of Residual Solvents: Cl