publication . Article . 2019

Planning a Programme of Pre-authorisation Clinical Trials of Medicines for the Treatment of Chronic Hepatitis C

Gubenko, A. I.; Eremenko, N. N.;
Open Access
  • Published: 25 Mar 2019
  • Publisher: SCEEMP
In 2016 the WHO Assembly defined a global strategy to combat viral hepatitis viruses, which seeks to eliminate these infections by 2030. The most important goals of this programme, adopted by 194 countries, are to reduce the incidence of viral hepatitis by 90 % and mortality rates – by 65 % as compared to the levels observed in 2016. Therefore, there is an obvious need for development of medicines for the treatment of chronic hepatitis C. The aim of the present paper was to determine basic approaches to planning pre-authorisation clinical trials for the main groups of medicines for the treatment of chronic hepatitis C. The paper summarises the current trends in ...
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free text keywords: chronic hepatitis c, pre-authorisation clinical trials, interferon alfa products, direct antivirals, interferon-free regimens, interferon-containing regimens, Hepatitis C, medicine.disease, medicine, Federal law, Guideline, Clinical trial, Mortality rate, Interferon alfa, medicine.drug, Disease, business.industry, business, Viral hepatitis, Intensive care medicine, medicine.medical_specialty, lcsh:Medicine (General), lcsh:R5-920
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