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2016年美国食品药品监督管理局(FDA)批准上市新药22种,其中化学小分子12个、生物制品10个。本文根据FDA批准的新药说明书以及相关文献和专利情况,简要介绍化学小分子药物的概况、适应证、作用机制、剂型规格、不良反应和合成路线等,以及生物制品的相关情况。
In 2016, the United States Food and Drug Administration (FDA) approved the listing of 22 new drugs, including 12 small chemical molecules and 10 biological products. This article based on the FDA approved new drug specification and related literature and patents, a brief overview of chemical small molecule drugs, indications, mechanism of action, dosage forms, adverse reactions and synthetic routes, and biological products related.