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Regulatory Research and Medicine Evaluation

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METHODOLOGY OF EXPERT EVALUATION OF MEDICINES

 
Issue Title
 
Vol 7, No 2 (2017) Safety Pharmacology Studies of Medicinal Products: Evaluation of Results Abstract   PDF (Rus)
G. N. Engalycheva, R. D. Syubaev, D. V. Goryachev
 
No 1 (2016) The landmarks of control and licensing system development for medicinal products in Russia (25 years since the establishment of the first state institution for expert evaluation of medicinal products) Abstract   PDF (Rus)
V. K. Lepakhin, Yu. V. Olefir, V. A. Merkulov, N. D. Bunyatyan, B. K. Romanov, A. N. Yavorsky, E. M. Rychihina
 
No 1 (2016) History and current status of biological tests in Russia Abstract   PDF (Rus)
M. S. Ryabtseva, T. A. Batuashvili, G. A. Sapozhnikova, N. P. Neugodova, Yu. V. Olefir, V. A. Merkulov
 
No 1 (2016) The development of microbiological methods for drug analysis Abstract   PDF (Rus)
O. V. Gunar, N. G. Sakhno, E. S. Novik, G. M. Bulgakova, L. V. Kolosova, I. A. Buylova, M. V. Roshchina
 
No 4 (2016) Modern approaches to vaccines interchangeability Abstract   PDF (Rus)
I. I. Snegireva, K. E. Zatolochina, M. A. Darmostukova, R. N. Alyautdin, B. K. Romanov
 
No 4 (2016) Standard instructions for medical use of interchangeable drugs: analysis of modern regulatory documents Abstract   PDF (Rus)
M. V. Zhuravleva, V. G. Kukes, Yu. V. Olefir, B. K. Romanov, A. B. Prokofiev, S. Yu. Serebrova, G. I. Gorodetskaya, V. V. Arkhipov, N. B. Lazareva
 
No 4 (2016) Alternative method for determining impurities in antimicrobial medicines Abstract   PDF (Rus)
S. I. Kuleshova, T. I. Pshenichnykh, E. P. Simonova
 
Vol 7, No 1 (2017) Methodological aspects of determining molecular mass distribution of dextrans by size-exclusion chromatography for various groups of medicines Abstract   PDF (Rus)
R. S. Smirnov, E. V. Ivanainen, A. I. Lutseva, O. A. Vaganova, D. A. Orlov
 
Vol 7, No 1 (2017) Use of columns with amine and nitrile sorbents for hydrophylic interaction liquid chromatography Abstract   PDF (Rus)
A. S. Osipov, O. A. Popova, T. N. Gretskaya, A. I. Sulimenkova, M. V. Nezdolieva
 
Vol 7, No 2 (2017) Methodological approaches to the choice of identification test methods for medicines Abstract   PDF (Rus)
A. I. Lutseva, T. N. Bokovikova, V. A. Yashkir, L. A. Stronova, N. E. Kuzmina, M. V. Agapkina, L. I. Panova, E. N. Popova, N. V. Gadasina, L. N. Bulanova, V. I. Prokofieva
 
Vol 7, No 2 (2017) Transfer of methods, and parameters of validation/verification Abstract   PDF (Rus)
S. I. Kuleshova
 
Vol 7, No 2 (2017) Hydrophylic interaction chromatography used for separation of hydroxycarbamide and urea Abstract   PDF (Rus)
A. S. Osipov, O. A. Popova, S. G. Larionova, E. Yu. Timoshina
 
Vol 7, No 2 (2017) On acceptable values of disregard limits for impurities and signal-to-noise ratio when checking chromatographic system sensitivity Abstract   PDF (Rus)
N. A. Epshtein
 
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