Generic drugs of direct antiviral action for the treatment of hepatitis C: features of bioequivalence studies
نویسندگان
چکیده
Introduction . In the last decade, approaches to treatment of chronic viral hepatitis C (HCV) have undergone significant changes. The new WHO strategy aims eliminate HCV by 2030 reducing number infections and deaths simplifying therapy. development drugs for patients with has a features, which requires compliance special recommendations conducting clinical bioequivalence studies. Aim study was analyze guidelines protocols studies Materials methods An information analytical method used evaluate according US Food Drug Administration, European Medicines Agency, WHO. Separately, an analysis permitted trials carried out data GRLS Ministry Health Russian Federation. Results discussions According results study, it noted that on therapy, is common develop principles planning research. Special attention paid preferred design study. It also necessary variability pharmacokinetic parameters substance under are calculate required volunteers be included in Conclusions Direct antiviral currently being conducted Federation, cover large list INN. entry reproduced into pharmaceutical market will improve patients’ access effective C. order conduct high-quality thoroughly familiarize yourself nosology manuals, critical assessment information, allow you choose appropriate correctly plan its conduct.
منابع مشابه
New treatment of hepatitis C (Direct Acting Antiviral)
Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Clinical care for the patients with HCV-related liver disease has advanced considerably thanks to an enhanced understanding of the pathophysiology of the disease, and because of developments in diagnostic procedures and improvements in therapy an...
متن کاملanalysis of reading comprehension needs of the students of paramedical studies: the case of the students of health information management (him)
چکیده ندارد.
15 صفحه اولstudy of cohesive devices in the textbook of english for the students of apsychology by rastegarpour
this study investigates the cohesive devices used in the textbook of english for the students of psychology. the research questions and hypotheses in the present study are based on what frequency and distribution of grammatical and lexical cohesive devices are. then, to answer the questions all grammatical and lexical cohesive devices in reading comprehension passages from 6 units of 21units th...
the impact of skopos on syntactic features of the target text
the present study is an experimental case study which investigates the impacts, if any, of skopos on syntactic features of the target text. two test groups each consisting of 10 ma students translated a set of sentences selected from advertising texts in the operative and informative mode. the resulting target texts were then statistically analyzed in terms of the number of words, phrases, si...
15 صفحه اولذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: ??????????? ?????
سال: 2023
ISSN: ['0235-1188', '2618-8961']
DOI: https://doi.org/10.21518/ms2023-143