S1A Need for Carcinogenicity Studies of Pharmaceut
分类： ICH指导原则
质量标准 新原料药和制剂的检测以及可接受标准：化学物质
This entry is part 26 of 53 in the series ICH指导原则
Q6A Specifications : Test Procedures and Acceptanc
生物技术产品的质量：rDNA衍生蛋白质产品生产细胞的表达构建体分析
This entry is part 25 of 53 in the series ICH指导原则
Q5B Quality of Biotechnological Products: Analysis
关于ICH区域内药典附录的评价及建议 —粉末的散装密度和振实密度测定法
This entry is part 23 of 53 in the series ICH指导原则
Q4B Annex 13 Q4B Annex 13 Bulk Density and Tapped
关于ICH区域内药典附录的评价及建议 —筛分法
This entry is part 22 of 53 in the series ICH指导原则
Q4B Annex 12 Analytical Sieving General Chapter 关于
关于ICH区域内药典附录的评价及建议 —毛细管电泳法
This entry is part 21 of 53 in the series ICH指导原则
Q4B Annex 11 Capillary Electrophoresis General Cha
关于ICH区域内药典附录的评价及建议 —聚丙烯酰胺凝胶电泳法通则
This entry is part 20 of 53 in the series ICH指导原则
Q4B Annex 10 (R1) Polyacrylamide Gel Electrophores
关于ICH区域内药典附录的评价及建议 -片剂脆碎度检查法
This entry is part 19 of 53 in the series ICH指导原则
Q4B Annex 9 (R1) Tablet Friability General Chapter
关于ICH区域内药典附录的评价及建议 —无菌检查法
This entry is part 18 of 53 in the series ICH指导原则
Q4B Annex 8 (R1) Sterility Test General Chapter 关于
关于ICH区域内药典附录的评价及建议 -溶出度检查法
This entry is part 17 of 53 in the series ICH指导原则
Q4B Annex 7 (R2) Dissolution Test General Chapter
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：原料药及其制剂的判定标准
This entry is part 15 of 53 in the series ICH指导原则
Q4B Annex 4C (R1) Microbiological Examination of N
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：控制菌检查法
This entry is part 14 of 53 in the series ICH指导原则
Q4B Annex 4B (R1) Microbiological Examination of N
关于ICH区域内药典附录的评价及建议-非无菌产品的微生物检查：微生物计数法
This entry is part 13 of 53 in the series ICH指导原则
Q4B Annex 4A (R1) Microbiological Examination of N
关于ICH区域内药典附录的评价及建议-注射剂装量检查法
This entry is part 11 of 53 in the series ICH指导原则
Q4B Annex 2 (R1) Test for Extractable Volume of Pa
关于在ICH区域内评估并推荐采用药典相关要求的指导原则
This entry is part 10 of 53 in the series ICH指导原则
Q4B Evaluation and Recommendation of Pharmacopoeia