An active pharmaceutical ingredient (API) is defined in ICH Q7 as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are ...
In this chapter, we’ll explore the different components of an API that we’ll have to name, some strategies we can employ to choose good names, the high-level attributes that distinguish good names from bad ones, and finally some general principles to help guide us when making tough ...
需要金币:*** 金币(10金币=人民币1元) PDA TR No. 56-治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用(API或生物活性成分)-2016(1).pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Technical Report No. 56 (Revised 2016) Application of Phase-Appropriate Quality System...
The beverage is used for general immunity improvement and as a preventive and curative agent for diseases of the digestive system. Sbiten’ is an ancient East Slavic fermented drink based on honey, water, and extracts of medicinal herbs and spices. It is used for preventive and curative ...