publication . Article . 2018

PLANNING AND EVALUATION OF BIOEQUIVALENCE STUDIES OF ATAZANAVIR PRODUCTS

Uvarova, N. E.; Eremenko, N. N.; Ramenskaya, G. V.; Goryachev, D. V.;
Open Access Russian
  • Published: 26 Sep 2018 Journal: Ведомости Научного центра экспертизы средств медицинского применения, volume 8, issue 3, pages 151-157 (issn: 1991-2919, eissn: 2619-1172, Copyright policy)
  • Publisher: OOO “Vashe Tsifrovoe Izdatelstvo”
Abstract
The Government of the Russian Federation approved the State strategy of combating the spread of HIV aimed at prevention of HIV epidemic. One of the goals of the Strategy is to increase the coverage of antiretroviral therapy for people infected with HIV, which includes extensive use of generic drugs. In order for a generic drug to be authorised, the applicant has to submit a report on the results of the bioequivalence studies in which the generic product was compared to the reference product. Atazanavir is an antiretroviral drug, which is also the drug of choice for the treatment and prevention of mother-to-child transmission of HIV. The aim of this study was to ...
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Medical Subject Headings: virus diseases
free text keywords: bioequivalence, bioequivalence study, atazanavir, generic drugs, highly variable drugs, pharmacokinetics, study design, Medicine (General), R5-920, Family medicine, medicine.medical_specialty, medicine, Generic drug, Christian ministry, Antiretroviral therapy, Antiretroviral drug, Atazanavir, medicine.drug, business.industry, business, Generic Product, Drug, media_common.quotation_subject, media_common, Bioequivalence
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