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Assessing Environmental Risks during the Drug Development Process for Parasitic Vector-Borne Diseases: A Critical Reflection
ACS Infectious Diseases ( IF 5.3 ) Pub Date : 2024-03-27 , DOI: 10.1021/acsinfecdis.4c00131
Kayhan Ilbeigi 1 , Carlos Barata 2 , João Barbosa 3 , Michael G. Bertram 4, 5, 6 , Guy Caljon 1 , Maria Paola Costi 7 , Alexandra Kroll 8 , Luigi Margiotta-Casaluci 9 , Eli S.J. Thoré 4, 5, 10 , Mirco Bundschuh 11, 12
Affiliation  

Parasitic vector-borne diseases (VBDs) represent nearly 20% of the global burden of infectious diseases. Moreover, the spread of VBDs is enhanced by global travel, urbanization, and climate change. Treatment of VBDs faces challenges due to limitations of existing drugs, as the potential for side effects in nontarget species raises significant environmental concerns. Consequently, considering environmental risks early in drug development processes is critically important. Here, we examine the environmental risk assessment process for veterinary medicinal products in the European Union and identify major gaps in the ecotoxicity data of these drugs. By highlighting the scarcity of ecotoxicological data for commonly used antiparasitic drugs, we stress the urgent need for considering the One Health concept. We advocate for employing predictive tools and nonanimal methodologies such as New Approach Methodologies at early stages of antiparasitic drug research and development. Furthermore, adopting progressive approaches to mitigate ecological risks requires the integration of nonstandard tests that account for real-world complexities and use environmentally relevant exposure scenarios. Such a strategy is vital for a sustainable drug development process as it adheres to the principles of One Health, ultimately contributing to a healthier and more sustainable world.

中文翻译:

评估寄生虫媒介传播疾病药物开发过程中的环境风险:一个重要的反思

寄生媒介传播疾病 (VBD) 占全球传染病负担的近 20%。此外,全球旅行、城市化和气候变化加剧了 VBD 的传播。由于现有药物的局限性,VBD 的治疗面临挑战,因为对非目标物种的潜在副作用引起了重大的环境问题。因此,在药物开发过程的早期考虑环境风险至关重要。在这里,我们检查了欧盟兽药产品的环境风险评估流程,并找出这些药物生态毒性数据的主要差距。通过强调常用抗寄生虫药物生态毒理学数据的缺乏,我们强调迫切需要考虑“同一个健康”概念。我们主张在抗寄生虫药物研发的早期阶段采用预测工具和非动物方法,例如新方法方法。此外,采用渐进方法来减轻生态风险需要整合非标准测试,这些测试考虑到现实世界的复杂性并使用与环境相关的暴露场景。这样的战略对于可持续的药物开发过程至关重要,因为它遵循“同一个健康”的原则,最终有助于建立一个更健康、更可持续的世界。
更新日期:2024-03-27
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