抗生素耐药与抗生素新药开发的研究进展

抗生素的发现和使用是20世纪最伟大的成就之一.随着抗生素的广泛应用,抗生素耐药成为药物使用时应重点关注的问题.抗生素耐药主要与细菌的自然选择、抗生素不合理使用有关,同时也使得抗生素新药的开发存在着诸多挑战.世界卫生组织(WHO)一直关注抗生素的危害和耐药问题,认为这些问题已经成为公共卫生和可持续医疗的最严重挑战.对抗生...

Research progress on antibiotic resistance and new antibiotics development

Reference list drug (RLD) refers to the reference drugs used in the research of generic drugs, which is one of the key factors in the development of generic drugs, and an important prerequisite for effective generic drug development and consistency evaluation. The policies and catalogues on RLD selection release and implementation for chemical generic drugs have effectively promoted the consistency evaluation of chemical generic drugs in China, and laid a solid foundation for the scientific supervision of drug safety and effectiveness. The main characteristics of the varieties that refused RLD applies were analyzed by combing the catalogue of RLD for chemical generics in China (public draft) from January 2020 to October 2021, and considerations were put forward in combination with various reasons for the failed applies. Aim to provides basis and reference for the promotion of reference selection as well as the projects establishment and development of chemical generic drugs.