用于治疗传染病的药物发展方案的管制办法

I. V. Lysikova, O. Basova
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引用次数: 0

摘要

2017年2月,世界卫生组织首次公布了耐抗生素“重点病原体”清单——对人类健康构成最大威胁的12种细菌的目录。该清单强调了对多种抗生素具有耐药性的革兰氏阴性菌所构成的危险。因此,开发新的抗微生物药物已成为一个紧迫的问题。该清单是确保和指导与新抗生素有关的研究与开发的重要参考点和激励措施,这将有助于解决全球对抗微生物药物日益增长的耐药性问题。该研究的目的是确定规划新的抗微生物药物临床前和临床开发规划的主要监管方法。根据俄罗斯联邦现行的要求和建议以及欧洲药品管理局的指导方针,考虑了规划抗菌药物开发方案的问题。作者分析了传染病药物临床前研究的主要阶段和方面(体外和体内特异性活性、PK-PD模型),以及临床试验阶段的要求,包括临床相关疗效和安全性终点选择的基本原理、研究设计和统计方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Regulatory Approaches to the Development Programme for Medicines Used to Treat Infectious Diseases
In February 2017 the World Health Organization first published the list of antibiotic-resistant «priority pathogens» — a catalogue of 12 species of bacteria that pose the greatest threat to human health. The list highlights the danger posed by Gramnegative bacteria that are resistant to multiple antibiotics. Thus, the development of new antimicrobial medicines is becoming a pressing issue. The list is an important reference point and incentive to secure and guide research and development related to new antibiotics that will help solve the issue of growing global resistance to antimicrobial medicines. The aim of the study was to determine the main regulatory approaches to planning preclinical and clinical development programmes for new antimicrobial medicines. On the basis of current requirements and recommendations in force in the Russian Federation and guidelines of the European Medicines Agency, the issues of planning antimicrobial drug development programs were considered. The autors analysed the main stages and aspects of preclinical studies of medicines for infectious diseases (specific activity in vitro and in vivo, PK-PD modeling), as well as requirements for the clinical trial stage, including the rationale for the choice of clinically relevant efficacy and safety endpoints, study design, and statistical methods.
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