Mitigating the risk of pharmaceuticals in the environment

澳门在线赌城娱乐正在与创新药物计划(IMI),重点关注环境中药物的优先排序和风险评估(PREMIER)。.

IMI是制药公司之间的公私伙伴关系, 欧洲委员会和欧洲制药工业协会联合会(EFPIA). 继5年IMI项目环境中药物智能评估(iPIE)成功之后, which concluded in June 2019, we are now launching the PREMIER project on 1 September 2020.

Led by AstraZeneca and Radboud University, along with nine other pharmaceutical companies (Bayer, BMS, Eli Lilly and Company, GSK, MSD, Novartis, Roche, Sanofi and Servier), the European Medicines Agency,  其他9个研究机构(荷兰国家公共卫生和环境研究所), University of Exeter, EAWAG, Fraunhofer Institute, University of Gothenburg, University of Helsinki, Leuphana University, 马里奥内格里研究所和约克大学)和四个中小型企业(生态, ECT, Simomics and TEAM IT), 该项目旨在提供一个创新的框架来描述活性药物成分(api)的环境风险。, which can be used to:

  • 开发工具和模型,在开发早期识别与api相关的潜在环境危害和风险
  • 筛选并优先考虑2006年之前授权使用的遗留api,以进行量身定制的环境评估
  • Explore the feasibility and practicality of greener drug design
  • 使api的环境数据对所有利益相关者更可见和可访问

Supported by the European Commission, 该项目受益于1000万欧元的投资,以资助研究目标. 总理项目具体旨在解决以下主题的 European Strategic Approach to manage the environmental risks of pharmaceuticals:

  • 支持发展对环境危害较小的药品,推动绿色生产
  • 改善环境风险评估及检讨(包括为2006年以前获批的原料药建立以科学为基础的跟进制度)
  • Expand environmental monitoring
  • Fill other knowledge gaps, reducing the data gap for pre-2006 drugs

 

 

IMI PREMIER项目是澳门第一赌城在线娱乐如何在环境保护和减轻药物对环境的风险方面处于领先地位的另一个例子. 投资这个项目将使澳门第一赌城在线娱乐能够评估和降低澳门第一赌城在线娱乐产品的环境风险,这样澳门第一赌城在线娱乐就可以继续向患者提供药物, without compromising our commitment to sustainability.

Professor Jason Snape Global Head of Environmental Protection, AstraZeneca

How we are mitigating the environmental risks associated with APIs

As a responsible healthcare company, we are committed to the health and safety of our society and planet. We make it a priority to effectively manage the risks associated with Pharmaceuticals in the Environment (PIE).

药物进入环境主要是由于患者的使用, where they can pass through our bodies and into waterways. 药品生产和对未使用药物的不当处理也增加了河流中药物的痕量水平, lakes, soils, and, sometimes, drinking water, resulting in the release of APIs into the environment. 一些药物可能会对水生生物产生低剂量和长期接触的潜在影响.

There are around 1,900 APIs in use, 然而,其中只有一小部分的环境风险得到了评估. In 2006, the requirement for Environmental Risk Assessments (ERAs) came into force in Europe requiring the long-term chronic risks of human medicinal products to be determined as part of their authorisation; many drugs approved prior to 2006 lack complete environmental risk assessment data. 这导致迫切需要制定务实的方法,以便根据潜在的环境风险对现有原料药进行优先排序,并确定正在开发的药物的环境危害.

Due to high attrition rates, the ERA for pharmaceuticals is typically conducted late in pharmaceutical development; in many cases these environmental studies are conducted in parallel to Phase III clinical trials. 据设想,PREMIER开发的工具将使环境因素能够更早地纳入药物开发过程.


As well as technical goals, such as predicting the hazard and environmental risk of future drugs, PREMIER项目旨在改善整个行业的治理和数据透明度. In addition, PREMIER provides an opportunity to build networks and partnerships, 汇集了对绿色药物开发和创新医学感兴趣的人士.

该项目已获得创新药物计划2联合承诺的资助,资助协议号为875508. 这项联合承诺得到了欧盟“地平线2020”研究和创新计划以及欧洲投资与投资协会的支持.

免责声明:上述通信反映作者的观点,既不代表IMI也不代表欧盟, EFPIA, 或任何关联伙伴对可能对其中包含的信息进行的任何使用负责.

 

tags

  • Sustainability