美国FDA 指导原则 根据《联邦食品、药品和化妆品法》第503B条指定用于复方的原料药的评价 英文原版.pdfVIP

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美国FDA 指导原则 根据《联邦食品、药品和化妆品法》第503B条指定用于复方的原料药的评价 英文原版.pdf

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) March 2019 Compounding and Related Documents Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B

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