三维导向转换模式在新药研究开发中的应用

近年来新药研究开发风险和难度逐渐增大，研发的成功率不增反降。我国新药研发模式存在的问题和不足正逐渐显露出来，在现行新药审批制度正趋于公正、科学、合理的大背景下，研发体系面临着巨大挑战的同时也迎来了新的发展机遇。现就新药研发过程中涉及的临床、市场及生产过程进行探讨，提出构建三维导向下的新药研发模式的重要性，并强调临床试验设计、市场需求以及生产过程的适应性问题是影响新药研发的关键因素，通过对问题的分析和讨论，以期提高新药研发的效率和成功率，为相关新药研究提供参考。

Application of translational three-dimension model to research and development of new drug

In recent years, risks and difficulties in the drug research and development (R&D) have been gradually increasing, while success rate has been cut down. Problems and defects of the pattern in new drug R&D are emerging. Under the overall background, the current new drug approval system tends to be unprejudiced, scientific, and rational, research systems are facing huge challenge while meeting a new developing opportunity. This paper has probed into clinic, market, and the procedure of production referring the process of R&D, hence putting forward the significance of the pattern under the three-dimensional guide, emphasizing that design of clinical trial, market demand, and adaptability in productive process are key factors in new drug R&D. By means of analysis and discussion on these problems, we hope to enhance the efficiency and success rate of new drug R&D while providing consults for relevant drug researches.