第五部分：Herbal products草药产品，该模块包括与草药相关的内容。包括Regulatory and scientific support法规和科学支持信息，Scientific guidelines科学指南、Q&A: Herbal medicines草药上市申请常见的问题的问与答、Procedures草药上市程序等。第三模块：“Veterinary regulatory兽用药品”，包括：1）Overview概述，有兽药整个生...
animals动物伦理、Innovation in medicines药物创新、Maximum residue limits最大残留限度、Quality by design质量源于设计、Scientific advice科学建议(包括:Antimicrobials抗菌剂、Quality质量及问答、Safety and residues安全和残留、Efficacy有效性、Immunologicals免疫药、Novel therapies新的治疗方法)、Scientific guidelines科学...
Quality of water for pharmaceutical use - Scientific guideline | European Medicines Agency (europa.eu)
点击“Scientific guidelines 科学指南”,这里可以下载大量的指南文件。包括Search guidelines搜索指南、Biologicals生物制品、Clinical efficacy and safety临床疗效和安全性、Clinical pharmacology and pharmacokinetics临床药理学和药代动力学、ICH(可下载所有ICH相关的指南)、Multidisciplinary综合学科、Non-clinical非临床、Q&A on...
animals动物伦理、Innovation in medicines药物创新、Maximum residue limits最大残留限度、Quality by design质量源于设计、Scientific advice科学建议(包括:Antimicrobials抗菌剂、Quality质量及问答、Safety and residues安全和残留、Efficacy有效性、Immunologicals免疫药、Novel therapies新的治疗方法)、Scientific guidelines科学...
所有API及制剂的新申请,以及对已批准申报的任何相关变更申请均应考虑本指南。 EMA制药用水指南原文可通过以下链接下载: Quality of water for pharmaceutical use - Scientific guideline | European Medicines Agency (europa.eu)
animals动物伦理、Innovation in medicines药物创新、Maximum residue limits最大残留限度、Quality by design质量源于设计、Scientific advice科学建议(包括:Antimicrobials抗菌剂、Quality质量及问答、Safety and residues安全和残留、Efficacy有效性、Immunologicals免疫药、Novel therapies新的治疗方法)、Scientific guidelines科学...
For each herbal substance, the binomial scientific name of the plant (genus, species, variety and author), chemotype (where applicable) and plant part have to be stated (Annex I of Directives 2001/83/EC or 2001/82/EC). 对于每一种草物质,必须说明该植物(属、种、品种和作者)、化学类型(如适...
The product formulation should be developed using sound prior knowledge, established scientific rationale and evidence. The resultant quality characteristics should be determined from multiple batches representative of the product to be marketed. 产品目标质量概况应考虑患者的可接受性、是否易于从容器中转移并给...
(https://www.ema.europa.eu/documents/scientific-guideline/guideline-quality-water-pharmaceutical-use_en.pdf) 中英文下载链接 链接:https://pan.baidu.com/s/1FzgfHcmiu2UL8X33a5Zj5A(https://pan.baidu.com/s/1FzgfHcmiu2UL8X33a5Zj5A) 提取码:fke7 发布于 2020-07-22 10:41:00 © 著作...