Search Results - "Romanov, B K"

Changes to the EAEU Guideline on Good Pharmacovigilance Practices by Romanov, B. K.

“…By Decision No. 81 of 19.06.2022, the Council of the Eurasian Economic Commission amended the Guideline on Good Pharmacovigilance Practices of the Eurasian…”
Get full text

Safety of COVID-19 vaccines by Romanov, B. K.

“…By June 1, 2022, there were 38 prophylactic COVID-19 vaccines approved in 197 countries around the world. The ongoing approval of new vaccines and the…”
Get full text

Preparation for the Inspection of the Pharmacovigilance System by Romanov, B. K.

“…The processes of planning, performing, documenting, and follow-up of pharmacovigilance system inspections are regulated by the Good Pharmacovigilance Practices…”
Get full text

Safety of Hydroxychloroquine, Favipiravir, and the Combination of Lopinavir and Ritonavir in the Treatment of the “First Wave” of the New Coronavirus Infection COVID-19 by Romanov, B. K.

“…The review compares individual case safety reports (ICSRs) for hydroxychloroquine, favipiravir, and the lopinavir/ ritonavir combination registered in the…”
Get full text

Coronavirus disease COVID-2019 by Romanov, B. K.

“…The paper presents data on the coronavirus diseaseCOVID-2019 caused by the SARS-CoV-2 coronavirus, which was temporarily named 2019-nCoV (2019 novel…”
Get full text

Audits and inspections of pharmacovigilance systems in Russia by Taube, A. A., Romanov, B. K.

“…The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of…”
Get full text

Need for the Development of Dialectical Thinking in Pharmaceutical Personnel to Improve Their Performance in the Pharmacovigilance System by Krasheninnikov, A. E., Romanov, B. K., Safiullin, R. S., Shestakov, N. V.

“…The pharmacovigilance system aimed at ensuring the safety of medicines has been functioning in Russia since 1997. However, at the moment, an important part of…”
Get full text

Limitations of NIR Spectrometry as an Identification Test for Active Ingredients in Medicinal Products by Kuz'mina, N. E., Moiseev, S. V., Romanov, B. K.

“…Near-infrared spectrometry (NIRS) is a new pharmacopoeial method. It is widely used in the pharmaceutical industry for quality control of medicinal products at…”
Get full text

Rate Setting for Labour Costs Related to Pharmacovigilance System Inspections by Abdrakhmanov, M., Alyautdin, R. N., Krasheninnikov, A. E., Romanov, B. K.

“…The inspection of pharmacovigilance systems is regulated by the Good Pharmacovigilance Practices (GVP) and local laws and regulations. Inspections may be…”
Get full text

Differences between the European and Eurasian Good Pharmacovigilance Practices by Matveev, A. V., Krasheninnikov, A. E., Matveeva, E. A., Romanov, B. K.

“…Good pharmacovigilance practices (GVP) of the Eurasian Economic Union (EAEU) were prepared based on the GVP of the European Medicines Agency that have been in…”
Get full text

Assessment of Safety Signals for Aztreonam in Different Age Groups: National and International Drug Safety Monitoring by Sokova, E. A., Arkhipov, V. V., Kazakov, A. S., Romanov, B. K., Alyautdin, R. N., Zhuravleva, M. V.

“…Aztreonam is the only approved monocyclic β-lactam antibiotic for human use that is active against Gram-negative aerobes, primarily Pseudomonas аeruginosa…”
Get full text

Literature Monitoring for Pharmacovigilance by Khudoshin, A. G., Xu, X., Romanov, B. K.

“…Literature monitoring is a complicated aspect of pharmacovigilance. The guidelines on good practice of pharmacovigilance of the Eurasian Economic Union…”
Get full text

Aspects of the Safe Use of Antibacterial Drugs in Community-Acquired Pneumonia: the Implications of Drug-Drug Interactions by A. A. Taube, B. K. Romanov, E. V. Shubnikova, R. N. Alyautdin, M. V. Zhuravleva, O. A. Demidova, E. Yu. Demchenkova

“…Background. Drug-drug interactions can seriously affect the safety profile of a drug and are an important problem worldwide. Due to the aging of the…”
Get full text

Classification of existing problems in the Russian pharmacovigilance system by Romanov, B. K., Krasheninnikov, A. E.

“…The pharmacovigilance system currently represents as a complex of interstate, state, departmental and public institutions. This system provides the receipt and…”
Get full text

Vaccination as an immune system status optimization tool for the high-performance sports: review by Konovalov, I. V., Zholinsky, A. V., Alpatov, S. P., Zorenko, A. V., Tochtieva, N. V., Romanov, B. K., Parastaev, S. A.

“…Objective: consideration of the importance of vaccination as a preventive measure of support the athlets immunne system in conditions of extreme physical…”
Get full text

Identification and Evaluation of Safety Signals of Drugs Currently under Development Using a Limited Data Set by Romanov, B. K., Zykova, N. I., Alyautdin, R. N., Olefir, Yu. V.

“…A recent increase in the number of safety signals of varying quality being submitted to the national and industry databases calls for the development of…”
Get full text

Interchangeability Issues with Glaucoma Medicines Using Latanoprost as an Example by Bunyatyan, N. D., Filippova, O. V., Romanov, B. K., Prokof’ev, A. B.

“…The possible interchangeability of eye drops was analyzed using glaucoma medicines containing latanoprost as examples. It was shown that the reference and…”
Get full text

Topical Issues of Drug Safety, Possibilities of Improving of Pharmacovigilance by Zhuravleva, M. V., Romanov, B. K., Gorodetskaya, G. I., Muslimova, O. V., Krysanova, V. S., Demchenkova, E. Yu

“…Since 2010, Russia has been developing new drug legislation, internal quality control and safety of medical organizations, and has developed algorithms for…”
Get full text

INFORMATION SYSTEM FOR EXPERT EVALUATION OF MEDICINES INTERCHANGEABILITY by Andreev, D. P., Rychikhina, E. M., Kozlovich, A. V., Romanov, B. K.

“…The article dwells upon the development and implementation of a computerised information system for automation of expert work related to evaluation of…”
Get full text

Analysis of Factors Influencing the Interchangeability of Antiepileptic Drugs by Alyautdin, R. N., Romanov, B. K., Pasternak, E. Yu, Bunyatyan, N. D., Merkulov, V. A.

“…The presence of several generics on the pharmaceutical market makes it possible to create a competitive environment and helps to reduce the costs of drug…”
Get full text