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.