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Botanical drug : ウィキペディア英語版 | Botanical drug
A botanical drug is defined in the United States Federal Food, Drug, and Cosmetic Act as a botanical product that is marketed as diagnosing, mitigating, treating, or curing a disease; a botanical product in turn, is a finished, labeled product that contains ingredients from plants. Chemicals that are purified from plants, like paclitaxel, and highly purified products of industrial fermentation, like biopharmaceuticals, are not considered to be botanical products. In 2006 the Food and Drug Administration approved the first botanical drug in the United States: sinecatechins, a green tea extract for genital warts.〔 ==Definition== A botanical drug is defined in the United States Federal Food, Drug, and Cosmetic Act (FD&C) as a botanical product that is marketed as diagnosing, mitigating, treating, or curing a disease; a botanical product in turn, is a finished, labeled product that contains vegetable matter as ingredients.〔U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). June 2004. (Guidance for Industry: Botanical Drug Products )〕 Chemicals that are purified from plants, like paclitaxel or artemisinin, and highly purified products of industrial fermentation, like biopharmaceuticals, are not considered to be botanical products.〔 The FD&C act separately regulates uses of botanical products as food (including dietary supplements), medical devices (e.g., gutta-percha), and cosmetics.〔
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Botanical drug」の詳細全文を読む
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