API 是有效成分，是仿制药用的名词；Drug Substance 是药的物质，是新药的有效成分。好像是相通的。
国外是没有原料药的概念，他们的原料是按化工产品管理的，不是药，只有制剂才是药。
研究生入门，主要是食品药品法律政策方向。最近一直翻译FDA有关文献，请问Drug Substance和API到底是翻译成...
Genotoxic impurities Evaluation in Active Pharmaceutical Ingredients (API)/ Drug SubstanceThe main areas discussed in this review are evaluation of control strategies of genotoxic impurities at different levels in the manufacturing of active pharmaceutical ingredients. The acceptable levels and control ...
Search PharmaCompass to find a CDMO, CMO offering drug substance development services for the custom synthesis of APIs (including HPAPIs) & intermediates as well as contract services like route scouting, scale up, process development, optimization, techn
aChemistry, Manufacturing, and Controls Section 化学、制造业和控制段[translate] aThe composition, manufacturing process, and controls for the drug substance (API) and the drug product (formulation) 构成、制造过程和控制为药物物质 (API) 和药品 (公式化)[translate]...
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance's molecular structure and/or descriptive information. marketing_category results.marketing_category string Product types are broken down into several potential...
1.The maximum daily dose of the API is so low that environmental exposure is not expected to rise to a level of concern, so the ERA can be concluded with no additional studies required; 2.The API is an endocrine active substance and ...
Placebo is a substance which do not contain any active ingredient, or any drug, rather it is designed to just look alike the actual drug dosage form, it is formulated by using sugar, or other inert pharmaceutical addaitives, it is widely used in research as control to find out the effect...
Drug Substance Working with a challenging API or complex process? Our development and manufacturing experts can help you get the science right as you scale. Learn More Drug Product Regardless of your finished dosage form, we can help you advance your product seamlessly through early development and...