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REGULATORY ISSUES

 
Issue Title
 
Vol 13, No 4 (2024) Prospects for optimizing the provision of medicines to pediatric patients based on the development of the pharmaceutical market in the segment of medicines for children Abstract   PDF (Rus)
O. D. Nemyatykh, E. A. Kovaleva, I. A. Narkevich
 
Vol 13, No 2 (2024) Outdated latin names of medicinal plants in the monographs of the State Pharmacopoeia of the Russian Federation, XIV edition (review) Abstract   PDF (Rus)
M. N. Povydysh, M. Yu. Goncharov
 
Vol 13, No 1 (2024) Affect of Features of a Microorganism Strain on a Scope of Exclusive Rights Abstract   PDF (Rus)
F. S. Ivanov, K. V. Nasonova
 
Vol 12, No 4 (2023): Supplement 1 Scientific, Methodological and Organizational Approaches to Conducting Pre-clinical and Expert studies of Substances with Psychoactive Properties Abstract   PDF (Rus)
T. L. Malkova, P. S. Mashchenko, A. I. Andreev, D. Yu. Apushkin, E. V. Vikhareva
 
Vol 12, No 4 (2023): Supplement 1 Creation of a Scientific System for Analyzing the Scientific Activities of a University as a Source of Innovation in the Production of Medicines Abstract   PDF (Rus)
E. V. Sokolova, P. S. Guryanov, A. G. Salnikova, T. L. Malkova
 
Vol 12, No 3 (2023) Methodological Approaches to Risk Management of Advanced Therapy Medicinal Products Abstract   PDF (Rus)
A. A. Taube, N. Yu. Velts
 
Vol 12, No 2 (2023) Regulation of the Launch of Orphan Drugs on the Market of the Eurasian Economic Union as a Mechanism to Increase the Availability of Treatment for Rare Diseases (Review) Abstract   PDF (Rus)
A. V. Foteeva, N. A. Koneva, O. S. Beloglazova, N. B. Rostova
 
Vol 12, No 1 (2023) About Analytical and Technological Reasons of Out-of-Specification Results for Assay and Disolution Tests (Review) Abstract   PDF (Rus)
N. A. Epshtein
 
Vol 11, No 4 (2022): Supplement 1 Destruction of Narcotic Drugs and Psychotropic Substances as a Stage of Circulation of Medicines Abstract   PDF (Rus)
T. L. Malkova, E. S. Berezina
 
Vol 11, No 4 (2022): Supplement 1 On the Issue of the Effectiveness of the Department for Registration of Medicines Abstract   PDF (Rus)
A. V. Foteeva, N. A. Koneva, N. B. Rostova
 
Vol 11, No 4 (2022): Supplement 1 On the Formation of Professionally Specialized Competencies and Training of Specialists and Managers in the Pharmacovigilance System of the Marketing Authorization Holder Abstract   PDF (Rus)
E. Yu. Kurganova, A. V. Soloninina
 
Vol 11, No 3 (2022) Issues of National Drug Security in Formation of a Reserve of Antibacterial Agents Intended to Eliminate Medical and Sanitary Consequences of Emergencies Abstract   PDF (Eng)
L. Yu. Chernikova, V. N. Dmitruk, N. L. Denisov, E. G. Morozova, A. V. Ratkin, E. V. Karakulova
 
Vol 11, No 1 (2022) Systematic approach to cross-contamination risk management in the production of medicinal products Abstract   PDF (Rus)
A. A. Dzerzhinskaya, A. A. Spiridonova, E. G. Khomutova
 
Vol 11, No 1 (2022) Mutual Recognition Procedure for the Registration of Medicines: New Challenges or Opportunities Abstract   PDF (Rus)
A. V. Foteeva, O. S. Barshadskaya, N. B. Rostova
 
Vol 11, No 1 (2022) Organization of Hygienic Monitoring of Working Area Air Pollution by Particulates in Pharmaceutical Industries (Review) Abstract   PDF (Rus)
I. A. Pozharnov, A. S. Simakov, A. A. Shatilina, G. V. Ramenskaya
 
Vol 10, No 4 (2021) The Use of Digital Technologies for the Purpose of Improving Methodological Approaches to the Creation of a Pharmaceutical Quality System at Enterprises for the Production of Medicines Abstract   PDF (Rus)
V. V. Goryachkin, V. А. Smirnov, V. N. Shestakov, R. A. Abramovich
 
Vol 10, No 4 (2021) Alternative Methods for Dissolution Profile Comparison in the Dissolution Test Abstract   PDF (Rus)
D. P. Romodanovsky, D. V. Goryachev
 
Vol 10, No 3 (2021) Scaling of the Granulation Process in the Conditions of GMP Training Center and Assessment of Possible Risks Abstract   PDF (Rus)
O. N. Abrosimova, M. A. Burakova
 
Vol 10, No 3 (2021) The Integrated Model of Quality Management System of Laboratory Studies of Medicines (Review) Abstract   PDF (Rus)   PDF (Eng)
A. I. Selezneva, V. A. Smirnov, V. V. Goryachkin, N. N. Chadova, S. V. Polyakov, V. N. Shestakov, R. A. Abramovich
 
Vol 10, No 3 (2021) Procedure for Reviewing Pharmaceutical Inspections in the Eurasian Economic Union (Review) Abstract   PDF (Rus)
A. P. Meshkovskiy, V. V. Beregovykh, V. N. Shestakov, N. V. Pyatigorskaya, Zh. I. Aladysheva, N. S. Nikolenko, A. M. Pyatigorskiy, E. I. Nesterkina
 
Vol 10, No 3 (2021) Labeling of Immunobiological Drugs, Produced by the Russian Research An-ti-Plague Institution "Microbe" of the Rospotrebnadzor (Review) Abstract   PDF (Rus)
A. V. Komissarov, O. A. Lobovikova, I. V. Shul'gina, V. S. Kostyuchenko, E. G. Abramova, O. A. Volokh, N. V. Sinitsyna, V. A. Demchenko, A. S. Fes'kova, A. K. Nikiforov
 
Vol 10, No 2 (2021) Transfer of Impurities Determination Methods: Comparative Testing, Validation, Acceptance Criteria (Review) Abstract   PDF (Rus)   PDF (Eng)
N. A. Epshtein
 
Vol 10, No 2 (2021) Documentation of Pharmaceutical Development. Part 2. Quality System Documents Abstract   PDF (Rus)
I. E. Smekhova, L. V. Shigarova, I. A. Narkevich, E. V. Flisyuk, V. D. Meteleva
 
Vol 10, No 2 (2021) Description of the System of State Registration of Medicines in the Republic of Georgia as a Development Potential of Domestic Manufacturers Abstract   PDF (Rus)
A. V. Foteeva, O. S. Barshadskaya, N. B. Rostova
 
Vol 10, No 2 (2021) The History of the Creation of the VII State Pharmacopoeia of the USSR (Review) Abstract   PDF (Rus)
K. S. Guzev
 
Vol 10, No 1 (2021) Guidelines for Promoting the Implementation of Pharmaceutical Quality Systems at EAEU Enterprises Through the Management of the Engagement of Production Personnel Abstract   PDF (Rus)
V. A. Smirnov, V. V. Goryachkin, V. N. Shestakov, R. A. Abramovich
 
Vol 10, No 1 (2021) Documentation of Pharmaceutical Development. Part 1. Study of the Documentation of the Site Abstract   PDF (Rus)
I. E. Smekhova, L. V. Shigarova, V. D. Meteleva, E. V. Flisyuk
 
Vol 10, No 1 (2021) Development of Retraining Systems for the Implementation of the Pharmaceutical Quality System at Pharmaceutical Production Enterprises of the EAEU Countries Abstract   PDF (Rus)
V. A. Smirnov, V. V. Goryachkin, V. N. Shestakov, R. A. Abramovich
 
Vol 9, No 4 (2020) N-nitrosamine Impurities in Medicines: Toxicity, Formation Pathways, Methods of Determination, and Limits (Review) Abstract   PDF (Rus)
P. P. Shchetinin, S. P. Senchenko, K. K. Gordeev
 
Vol 9, No 4 (2020) The Modern Concepts of Pharmaceutical Development in the Context of the Transition to a Uniform Regulation of Medicinal Products Circulation Abstract   PDF (Rus)
A. E. Feofilova, A. V. Foteeva, N. B. Rostova
 
Vol 9, No 4 (2020) Responsibilities of the Marketing Authorisation Holders in Respect of GMP Compliance (Review) Abstract   PDF (Rus)
A. P. Meshkovskiy, N. V. Pyatigorskaya, Z. I. Aladysheva, V. V. Beregovykh, A. M. Pyatigorskiy, N. S. Nikolenko, M. M. Marshalova, V. V. Belyaev
 
Vol 9, No 3 (2020) Evaluation of New Risk-based Regulatory Approach to Classification of GMP Deficiencies (Review) Abstract   PDF (Rus)
V. N. Shestakov, Yu. V. Podpruzhnikov
 
Vol 9, No 3 (2020) Metrological Requirements to Measuring Equipment (Review) Abstract   PDF (Rus)
N. V. Shineva, M. V. Gavrilin, Yu. A. Starchak, S. V. Makarov
 
Vol 9, No 3 (2020) Transfer of Analytical Procedures (Review) Abstract   PDF (Rus)
Yu. A. Starchak, M. V. Gavrilin, N. V. Shineva
 
Vol 9, No 2 (2020) Assessing the Correlation Between GMP Deviations and Potential Quality Defects of Medicinal Products: the Result of the Survey of Qualified Persons Abstract   PDF (Rus)
V. A. Orlov, V. N. Shestakov
 
Vol 9, No 1 (2020) Review of Post-registration Changes in the Life Cycle of Сholera Bivalent Chemical Vaccine (Review) Abstract   PDF (Rus)
I. V. Shulgina, O. A. Lobovikova, O. A. Voloh, O. V. Gromova, A. K. Nikiforov, A. V. Komissarov, V. A. Demchenko, A. S. Fes’kova, S. S. Galetova, N. P. Mironova, V. I. Pavlova
 
Vol 8, No 3 (2019) Planning and Evaluation of Bioequivalence Studies of Telmisartan Generic Drug Products Abstract   PDF (Rus)
A. L. Khokhlov, D. P. Romodanovsky, A. E. Miroshnikov
 
Vol 8, No 2 (2019) Validation of Analytical Procedures: Graphic and Calculated Criteria for Assessment of Methods Linearity in Practice Abstract   PDF (Rus)
N. A. Epshtein
 
Vol 8, No 1 (2019) REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW) Abstract   PDF (Rus)
O. A. Lobovikova, I. V. Shul'gina, E. G. Abramova, A. K. Nikiforov, A. V. Komissarov, V. A. Demchenko, A. G. Selezneva, A. S. Fes'kova, S. S. Galetova, N. P. Mironova
 
Vol 8, No 1 (2019) USE OF SIBUTRAMIN IN PHARMACEUTICAL DRUGS AND ANOREXIC DIETARY SUPPLEMENTS (REVIEW) Abstract   PDF (Rus)
A. M. Sukhanova, I. B. Perova, G. M. Rodionova, K. I. Eller, V. I. Gegechkori
 
Vol 8, No 1 (2019) THE PROGRAM OF ADAPTATION AND PROFESSIONAL DEVELOPMENT OF PERSONNEL WITHIN A QUALITY MANAGEMENT SYSTEM OF THE PHARMACEUTICAL ORGANIZATION (REVIEW) Abstract   PDF (Rus)
N. G. Zolotareva, S. V. Strelkov, V. A. Strelkova
 
Vol 8, No 1 (2019) CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW) Abstract   PDF (Rus)
N. A. Epshtein
 
Vol 8, No 1 (2019) CERTIFICATION OF QUALITY MANAGEMENT SYSTEM OF LLC «CENTER OF PHARMACEUTICAL ANALYTICS» ACCORDING TO THE REQUIREMENTS OF ISO 9001:2015 (GOST R ISO 9001-2015) (REVIEW) Abstract   PDF (Rus)
A. A. Krylatova, I. E. Shohin, E. P. Obrazcova
 
No 1 (2016) POTENT NON-NARCOTIC ANALGESICS AS А DIRECTION IN DEVELOPMENT OF PHARMACEUTICALS Abstract   PDF (Rus)
A. V. Sosnov, S. V. Sadovnikov, F. M. Semchenko, K. A. Rufanov, V. N. Tohmahchi, A. A. Sosnova, I. A. Tyurin
 
No 2 (2017) THE ANALYSIS OF THE PHARMACEUTICAL MARKET ON THE EXAMPLE OF MEDICINES OF GROUP OF INHIBITORS OF THE PROTON POMP Abstract   PDF (Rus)
N. V. Mazova, A. L. Marchenko, N. V. Marchenko
 
No 4 (2018) THE ROLE OF THE SCIENTIFIC OVERVIEWS IN THE GENERIC DRUG REGISTRATION PROCESS IN THE RUSSIAN FEDERATION AND EURASIAN ECONOMIC UNION Abstract   PDF (Rus)
K. S. Milchakov
 
No 1 (2016) THE PROCEDURE OF ACTIVE PHARMACEUTICAL INGREDIENT SUPPLIERS PRELIMINARY CHOICE FOR MEDICINE MANUFACTURE Abstract   PDF (Rus)
S. A. Zaitsev, A. V. Basevich, A. O. Hrustaleva
 
No 2 (2017) PROBLEMS OF CONFORMITY OF THE RECORDS INTEGRITY WITH THE REQUIREMENTS OF GOOD MANUFACTURING PRACTICE. REPORT 1. ACTUALITY OF THE RECORDS INTEGRITY CONSERVATION Abstract   PDF (Rus)
I. A. Osmolovskaya, O. V. Zarochinskaya, M. O. Emelianov, D. V. Somov
 
No 1 (2016) REFERENCE STANDARDS OF ACTIVE INGREDIENTS OF POTENT ANALGESIC DRUGS Abstract   PDF (Rus)
A. V. Sosnov, S. S. Golubev, B. S. Punkevich, S. V. Sadovnikov, E. M. Zagrebin, I. S. Rodina, F. M. Semchenko, A. A. Sosnova
 
No 3 (2017) ANALYSIS OF THE SYSTEM ORGANIZATION OF PHARMACEUTICAL DRUG DEVELOPMENT Abstract   PDF (Rus)
S. A. Rozhnova, A. V. Tsypkina
 
No 1 (2016) RISK ANALYSIS OF THE DEFICIENCIES FOUND BY THE GMP INSPECTIONS Abstract   PDF (Rus)
Yu. V. Podpruznikov, V. N. Shestakov
 
No 3 (2017) TABLETS. REGULATORY REQUIREMENTS OF THE STATE PHARMACOPOEIA XIII EDITION Abstract   PDF (Rus)
N. V. Isaeva, A. I. Tulaykin, E. V. Sheshegova
 
No 1 (2016) ESTABLISHMENT OF FEATURES DESCRIPTION OF OBJECT GOVERNMENT PROCUREMENT «MEDICINAL PRODUCTS» AS A CONDITION OF GRANTING PREFERENCES TO LOCAL PRODUCERS Abstract   PDF (Rus)
I. A. Narkevitch, Z. M. Golant, N. S. Kartashova
 
No 4 (2017) MULTIPLE VIEW MARKETING ANALYSIS OF THE RUSSIAN PLANT-BASED DRUGS MARKET Abstract   PDF (Rus)
A. V. Akamova, O. D. Nemyatykh, I. A. Narkevich
 
No 3 (2016) THE ROLE OF REFERENCE STANDARDS IN QUALITY ASSURANCE FOR MEDICINES: REGULATORY AND METROLOGICAL ASPECTS Abstract   PDF (Rus)
D. A. Leontiev, Y. V. Podpruzhnikov, N. V. Volovyk
 
No 4 (2017) GLOBAL PHARMACEUTICAL MARKET TRENDS: OPPORTUNITIES FOR DEVELOPMENT Abstract   PDF (Rus)
D. A. Demidyonok, T. A. Petrova, I. A. Narkevich, V. A. Markova
 
No 3 (2016) THE PROSPECTS OF THE USING OF THE REGISTER OF THE STANDARD LABELS OF THE INTERCHANGEABLE MEDICINES TO IMPROVE OF DRUG SUPPLY OF PEDIATRIC PATIENTS Abstract   PDF (Rus)
G. Ia. Ibragimova, A. Kh. Gaisarov, R. V. Nasyrov
 
No 4 (2017) THE DEVELOPMENT OF THE FUNCTIONAL MODEL OF THE CONDUCTING ACTIVITIES IN PHARMACIES FOR IMPLEMENTATION OF PHARMACOVIGILANCE Abstract   PDF (Rus)
G. Ia. Ibragimova, A. Kh. Gaisarov
 
No 3 (2016) PHARMACEUTICAL DEVELOPMENT OF DRUGS FOR PEDIATRIC PRACTICE: FUNDAMENTAL BASES AND SPECIFIC FEATURES Abstract   PDF (Rus)
I. A. Narkevich, O. D. Nemyatykh, I. I. Basakina, D. D. Siukaeva
 
No 4 (2017) COMPREHENSIVE ASSESSMENT OF THE MARKET DRUGS FOR TREATMENT OF PNEUMONIA IN PEDIATRICS Abstract   PDF (Rus)
D. D. Siukaeva, O. D. Nemyatyh, I. A. Narkevich, N. I. Pavlenko
 
No 3 (2016) REVIEW, CHARACTERISTICS AND ANALYSIS OF THE LAST CHANGES IN THE GMP REQUIREMENTS Abstract   PDF (Rus)
Yu. V. Podpruznikov, V. N. Shestakov
 
No 1 (2018) COMPARATIVE ANALYSIS OF THE DOMESTIC AND FOREIGN PHARMACEUTICAL MARKETS FOR THE NOSE WITH THE PURPOSE OF SEARCHING FOR FUTURE DEVELOPMENT PROSPECTS Abstract   PDF (Rus)
M. Yu. Kinev, A. Yu. Petrov
 
No 1 (2017) PARTICIPANTS OF THE «COLD CHAIN»: ANALYSIS OF COMPLIANCE WITH THE RULES OF THE GDP Abstract   PDF (Rus)
I. A. Narkevich, V. A. Markova, D. A. Demidyonok
 
No 1 (2018) CERTIFICATION FOR THE CONFORMITY OF ISO 9001 EQUIREMENTS AS A FIRST PHASE OF IMPLEMENTATION OF GOOD LABORATORY PRACTICE IN THE CENTER OF EXPERIMENTAL PHARMACOLOGY Abstract   PDF (Rus)
I. A. Narkevich, E. V. Flisyuk, A. V. Moskvin, L. V. Shigarova, D. Y. Ivkin, A. S. Ivkina
 
No 2 (2016) TOPICAL ISSUES OF TRAINING OF GMP INSPECTORS Abstract   PDF (Rus)
V. N. Shestakov, Yu. V. Podpruzhnikov
 
No 1 (2017) THE ROLE OF SMALL INNOVATIVE ENTERPRISES IN THE DEVELOPMENT AND MARKET LAUNCH OF INNOVATIVE DRUGS Abstract   PDF (Rus)
A. A. Semin, I. A. Narkevich
 
No 2 (2018) OVERVIEW OF GMP INSPECTIONS RESULTS OF FOREIGN MANUFACTURING SITES IN 2017 Abstract   PDF (Rus)
V. A. Orlov
 
No 2 (2016) ASSESSMENT OF THE RUSSIAN FEDERATION REQUIREMENT IN POTENT ANALGESICS Abstract   PDF (Rus)
A. V. Sosnov, S. S. Golubev, B. S. Punkevich, S. V. Sadovnikov, F. M. Semchenko, V. N. Tohmahchi, A. A. Sosnova
 
No 1 (2017) AN OVERVIEW OF THE MAIN CHANGES IN THE RULES OF GOOD LABORATORY PRACTICE (THE ORDER FROM 01 APRIL 2016 № 199n ENTERED INSTEAD OF THE ORDER OF MINISTRY OF HEALTH OF 23 AUGUST 2010 №708n) Abstract   PDF (Rus)
M. S. Zhuravleva, M. V. Lebedeva
 
No 2 (2018) POTENTIAL OF THE RUSSIAN FEDERATION IN EXPORTS OF ANTI-INFLUENZA VACCINES IN LATIN AMERICAN COUNTRIES Abstract   PDF (Rus)
V. P. Trukhin, I. A. Narkevich, E. P. Nacharova, S. V. Uiba, I. I. Basakina
 
No 2 (2016) TERM EXTENSION OF DRUG PATENTS IN RUSSIA (REVIEW OF LEGISLATION AMENDMENTS) Abstract   PDF (Rus)
K. V. Osipov
 
No 1 (2017) PHARMACEUTICAL CO-CRYSTALLS. FEATURES OF ASSESING THE PATENTABILITY Abstract   PDF (Rus)
S. A. Sinchenko
 
No 2 (2018) COMPREHENSIVE MARKETING STUDY OF THE RUSSIAN PHARMACEUTICAL MARKET DRUGS FOR PREVENTION AND TREATMENT OF DISEASES OF THE THYROID GLAND Abstract   PDF (Rus)
V. I. Zvereva, O. A. Semkina, E. I. Gribkova
 
No 2 (2016) COMPARISON OF RUSSIAN AND FOREIGN HYGIENIC PARAMETERS OF MEDICINES PERMISSIBLE EXPOSURE LIMIT Abstract   PDF (Rus)
S. S. Rozhkov, A. V. Smirnov
 
No 2 (2017) ANALYTICAL REVIEW OF THE NORMATIVE BASE TO PROVIDE THE GOOD QUALITY OF PRECLINICAL STUDIES IN RUSSIA Abstract   PDF (Rus)
A. I. Selezneva, S. V. Glembotsky, S. V. Polyakov, M. N. Makarova, V. G. Makarov, A. A. Churin
 
No 3 (2018) RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION Abstract   PDF (Rus)
N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva
 
No 4 (2016) EXPERIENCE OF CERTIFICATION BIOANALYTICAL LABORATORY ACCORDING TO REQUIREMENTS OF GOST 33044-2014 «PRINCIPLES OF GOOD LABORATORY PRACTICE» (GLP) Abstract   PDF (Rus)
A. A. Krylatova, I. E. Shohin, E. P. Obrazcova, A. O. Monaenkov
 
No 2 (2017) THE ANALYSIS OF THE ACTIVITIES OF THE CENTERS FOR THE DEVELOPMENT OF DRUGS, CREATED ON THE BASIS OF EDUCATIONAL ORGANIZATIONS Abstract   PDF (Rus)
A. A. Semin, I. A. Narkevich
 
No 3 (2018) MODERN ASPECTS OF PATENT PRACTICE IN THE ACTIVITY OF THE SCIENTIFIC RESEARCH INSTITUTE Abstract   PDF (Rus)
A. I. Gromakova, E. V. Korol, O. A. Semkina
 
No 4 (2016) REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS Abstract   PDF (Rus)
K. A. Yatsenko, V. S. Berezina
 
No 2 (2017) KEY TRENDS ANALYSIS OF RESULTS OBTAINED FROM INSPECTING THE FOREIGN MANUFACTURERS OF MEDICINAL PRODUCTS IN 2016 Abstract   PDF (Rus)
V. A. Orlov
 
No 4 (2018) AN EXPERIENCE OF IMPLEMENTING LIMS SYSTEM IN THE BIOANALYTICAL LABORATORY (PART 1) Abstract   PDF (Rus)
A. A. Krylatova, I. E. Shohin, A. S. Kardashin
 
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