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抗生素和祛痰药组成的复方口服制剂是近几年我国抗生素领域的研发和注册申报热点。由于申报者对该类复方制剂在国外上市的研究不足,立题合理性尚待商榷,在明确其安全性的基础上,应通过合理设计并严格控制的临床试验,来评价其临床价值和临床定位。目前已完成的相关临床试验中存在一些设计上的问题。本文根据新药审评的相关原则,结合相关文献和具体审评经验,探讨此类复方制剂临床试验需关注的问题。
Antibiotics and expectorants composed of compound oral preparations in recent years, the field of antibiotics in China R & D and registration of hot spots. Because of the lack of research on the listing of such compound preparations in foreign countries, the reasonableness of the issue remains to be discussed. On the basis of a clear definition of its safety, the clinical value and clinical evaluation should be evaluated through a properly designed and controlled clinical trial Positioning. There are some design issues in the related clinical trials that have been completed so far. This article based on the relevant principles of the review of new drugs, combined with relevant literature and specific review experience to explore such clinical trials of compound preparations need to focus on issues.