摘要
2017年1月,美国和欧盟共批准20个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。
In January 2017, US Food and Drug Administration(FDA) and European Commission had totally approved 20 new drugs, including new molecular entities, new active ingredients, new biologics and new line extensions(new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their first global approval were analyzed with emphasis on the outcomes of clinical trials and development histories.
出处
《药学进展》
CAS
2017年第2期158-160,共3页
Progress in Pharmaceutical Sciences