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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。
In recent years, the risk and difficulty of research and development of new drugs gradually increase, and the success rate of research and development does not increase or decrease. Problems and shortcomings in the R & D mode of new drugs in our country are gradually revealed. Under the current background of the current drug approval system being more just, scientific and reasonable, the research and development system is facing great challenges as well as new opportunities for development. Now, we discuss the clinical, market and production processes involved in the research and development of new drugs and put forward the importance of building a new drug research and development model under the guidance of three dimensions. We also stress that the adaptability of clinical trial design, market demand and production process is affecting the development of new drugs Key factors, through the analysis and discussion of the problem, in order to improve the efficiency and success rate of new drug research and development, provide a reference for the related new drug research.