医药产品开发过程中创新项目技术准备程度的综合评估

A. M. Pyatigorsky, G. Brkich, V. Beregovykh, N. Pyatigorskaya
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引用次数: 0

摘要

在俄罗斯开展的大多数研发、技术和实验工作导致技术开发的准备程度较低,无法融入工业企业的生产周期,这一方面表明开发人员对产品生命周期的要求缺乏了解,另一方面,这可能是俄罗斯在世界高技术产品出口总额中所占份额较低的原因。为了在目标时间内建立科学技术储备,世界上的做法是使用技术准备水平(TRL)量表。这种方法被用于各种行业,并显示出在目标时间内开发技术和推出创新产品的可能性。然而,教育和科学部指出,这种方法尚未用于确定化学技术过程和制药技术的准备程度。本文讨论了与在药品开发过程中对创新项目的技术准备水平进行全面评估相关的主要科学问题,基于对药物生命周期过程的科学理解,使用TRL规模和QbD概念作为系统和早期开发方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comprehensive Assessment of Technological Readiness of an Innovative Project during the Development of a Pharmaceutical Product
Most of RD, technological and experimental works carried out in Russia result in the development of technologies with low-level readiness for possible integration into the production cycles of industrial enterprises, which, on the one hand, demonstrates a lack of understanding by developers of the requirements for the product life cycle, and on the other hand, it is the possible reason for the low share of Russia in the total world exports of high-technology goods. In order to create a scientific and technical reserve in a target time, the world practice uses the Technology Readiness Levels (TRL) scale. This approach is used in various industries and has shown the possibility to develop technologies and launch production of innovative product by a target time. However, the Ministry of Education and Science notes that this approach has not yet been used to determine the readiness levels of chemical-technological processes and pharmaceutical technologies. The article discusses main scientific problems associated with conducting a comprehensive assessment of technological readiness levels of an innovative project during the development of a pharmaceutical product, using the TRL scale and the QbD concept for a systematic and early approach to development, based on a scientific understanding of the drug life cycle processes.
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