publication . Article . 2019

Regulatory Approaches to the Development Programme for Medicines Used to Treat Infectious Diseases

Lysikova, I. V.; Basova, O. I.;
Open Access Russian
  • Published: 03 Dec 2019 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 9, issue 4, pages 231-240 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
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 appr...
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free text keywords: antimicrobial medicines, bacteria, preclinical studies, clinical studies, multiple drug resistance, efficacy, safety, Medicine (General), R5-920, Human health, Medicine, business.industry, business, Incentive, Antimicrobial, World health, Family medicine, medicine.medical_specialty, Russian federation, Clinical trial, Antimicrobial drug
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