申请人应在申请中提供有关上游流程的信息,以证明拟议的起始材料的合理性,包括持续存在的杂质控制策略。参考文献:Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers 作者精彩原创集锦 1、...
申请人应在申请中提供有关上游流程的信息,以证明拟议的起始材料的合理性,包括持续存在的杂质控制策略。 参考文献:Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Questions and Answers
ChapterQ4BAnnex12AnalyticalSievingGeneralChapterQ4BAnnex13BulkDensityandTappedDensity ofPowdersGeneralChapterQ4BAnnex14BacterialEndotoxinsTestGeneral ChapterQ4BFAQsFrequentlyAskedQuestions Q5A-Q5EQualityofBiotechnologicalProducts生物技术产品的质量 Q5A(R1)ViralSafetyEvaluationofBiotechnologyProductsDerivedfromCellLinesofHuman...
S3A Implementation Working Group Questions and AnswersS3A 问答 毒代毒代动力学指导原则说明:毒性研究中的全身暴露量评价-聚焦于微量采样阶段32016.1.19有 S3B: Pharmacokinetics Guidance for Repeated Dose Tissue Distribution StudiesS3B:药代动力学:重复给药的组织分布研究指导原则阶段51994.10.27有 ...
16、dients活性药物成份的GMP指南 Q7 Q&As Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients a14Q8 Pharmaceutical Development药物开发药物开发Q8(R2) Pharmaceutical Development 药物开发药物开发Q8/9/10 Q&AsR4Q8/Q9/Q10 - Implementation a15Q9 Quality Risk Management质量...
Q1Stability（稳定性）Q1A(R2)QualityGuidelines（质量）Step5 2003-2-6 Q1B Step5 1996-11-6 Q1C Step5 1996-11-6 内容 StabilityTestingofNewDrugSubstancesandProducts新原料药和制剂的稳定性试验StabilityTesting:PhotostabilityTestingofNewDrugSubstancesandProducts稳定性试验：新原料药和制剂的光稳定性试验 Stabili...
Q11 Q&As Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances Q12 Lifecycle Management 生命周期管理 Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Cross-cutting Topics Cross-cutting Guidelines Safet...
S3A - S3B Toxicokinetics and Pharmacokinetics/毒代动力学和药代动力学 S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A:毒理动力学指导原则说明:毒性研究中系统性暴露的评价 1994.10.27 S3A Implementation Working Group Questions and Answers S3A实施工作...
Q1Stability/ 稳定性 Q1A(R2):StabilityTestingofNewDrugSubstancesandProductsQ1A(R2):新型原料药和药品的稳定性测试阶段5 Q1B:StabilityTesting:PhotostabilityTestingofNewDrugSubstancesandProductsQ1B:稳定性测试:新型原料药和药品的光稳定性测试阶段5 Q1C:StabilityTestingforNewDosageFormsQ1C:新剂型的稳定性测试阶段5...
Q1EQ1EEvaluationofStabilityDataEvaluationofStabilityData稳定性数据的评估稳定性数据的评估 Q1FQ1FStabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIVStabilityDataPackageforRegistrationApplicationsinClimaticZonesIIIandIV 在气候带在气候带IIIIII和和IVIV,药物注册申请所提供的稳定性数据,药物注册申请所提供...