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纳米药物设计与负责任创新:建构论视角的解释

         

摘要

The design of drug is the initial stage of life cycle of a drug,and it is also a key link to control the risk of drug. The design of Nano -drug will be to realize the risk control of the “origin”governance.The method of value sensitive de-sign (value embedded)used to design process showed the consciousness of responsible innovation of designers.The re-sponsibility of designers objectively caused by the structure effect and size effect of nano -preparation not only includes the responsibility of the technical assessment (TA)related to risk of nano -drug,and but also needs to study a system of con-structive technology assessment (CTA)linking with risk from the constructivism perspective.The theory basis for construc-ting risk assessment of Nano -drug is the humanism theory of Marxism and stakeholder theory.The designers of Nano -drug implement the path of responsible innovation which should pay attention to the four dimensions of promotion of knowl-edge,codes of ethics,legal constraints and policy orientation.%药物设计是药品生命周期的起始阶段,也是控制药品风险的关键环节。纳米药物设计是实现风险控制的“源头”治理,设计过程采用的价值敏感设计(价值嵌入)方法是设计者负责任创新意识的展现。由纳米制剂的结构效应和尺寸效应客观决定的纳米药物设计者责任,不仅表现为对纳米药物风险的技术评估(TA)的责任,而且需要从建构论视角探索纳米药物风险的建构性技术评估(CTA)体系。建构性纳米药物风险评估的理论基础是马克思主义的“人本”理论和利益相关者理论。纳米药物设计者实施负责任创新的路径应关注知识提升、道德规范、法律制约及政策导向4个维度。

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