Drug Products:The finished dosage form (tablet,capsule,etc.) that contains a drug substance--generally,but not necessarily,in association with other active or inactive ingredients. 简言之,前者就是那些可以药用的物质,比如人参、枸杞或其它化学物质.而后者只是最终制成的你可以服用的药,它们可以含drug ...
Drug substance:The active ingredient intended to diagnose,treat,cure,or prevent disease or affect the structure or function of the body,excluding other inactive substances used in the drug product.Drug Products:The finished dosage form (tablet,capsule,etc.) that contains a drug substance--generally...
Drug substance:The active ingredient intended to diagnose,treat,cure,or prevent disease or affect the structure or function of the body,excluding other inactive substances used in the drug product.Drug Products:The finished dosage form (tablet,capsule,etc.) that contains a drug substance--generally...
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。
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FDA,GMP,ICH临床实验专业英语词汇互译 ... drug product: 药物产品drug substance:原料药established name: 确定的名 … www.360doc.com|基于106个网页 2. 为原料药 药品注册... ... drug product 制剂。 (drug substance为原料药) drug production/ manufacture and distribution 药品生产和流 … ...
A drug is any chemical substance that affects the functioning of living things and the organisms (such as bacteria, fungi, and viruses) that infect them.
Food and Drug Administration (FDA) regulations define a listed drug as a new drug product that has been approved for safety and effectiveness under the relevant regulations. FDA identifies in the Orange Book listed drugs that have been designated...
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