Zobrazeno 1 - 10
of 41
pro vyhledávání: '"E V, Shubnikova"'
Autor:
E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 3, Pp 309-330 (2024)
INTRODUCTION. Postmarketing surveillance is the main mechanism to monitor and evaluate the safety of drugs approved for widespread clinical use. This mechanism provides up-to-date information on adverse drug reactions and facilitates the implementati
Externí odkaz:
https://doaj.org/article/4627d7be30994585930da3fb93840522
Autor:
T. M. Bukatina, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 2, Pp 201-213 (2024)
INTRODUCTION. A risk management plan (RMP) is an important document for assessing and managing risks when using a medicinal product. An RMP is provided as part of the marketing authorisation application for a medicinal product. The requirements for t
Externí odkaz:
https://doaj.org/article/02c1e5f5d6ee40a99d9ef960cf955453
Current Information on the Safety of Medicinal Products: Decisions of Foreign Regulatory Authorities
Autor:
E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 12, Iss 1, Pp 117-120 (2024)
The experts of the Department for Medicine Safety Evaluation of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of international pharmacovigilance regulatory authorities on the necessary labelling u
Externí odkaz:
https://doaj.org/article/21830f780d4147f99c7392f27797999a
Autor:
T. M. Bukatina, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 11, Iss 1, Pp 30-37 (2023)
The Council of the Eurasian Economic Commission published Decision No. 81 “On Amendments to the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” on 19 June 2022 and enacted it on 6 December 2022. A risk management plan (RM
Externí odkaz:
https://doaj.org/article/d4c7ef2297034442b9c3ec0d9c4a8568
Autor:
E. V. Shubnikova, N. Yu. Velts
Publikováno v:
Антибиотики и Химиотерапия, Vol 67, Iss 11-12, Pp 79-90 (2023)
Aminoglycosides are broad-spectrum antibacterial agents used in the treatment of urinary tract infections, tuberculosis, visceral leishmaniasis, sepsis in newborns, as well as cystic fibrosis. However, the use of aminoglycosides is limited due to the
Externí odkaz:
https://doaj.org/article/3ce417a63929421495e2982b90498d85
Autor:
A. A. Taube, B. K. Romanov, E. V. Shubnikova, R. N. Alyautdin, M. V. Zhuravleva, O. A. Demidova, E. Yu. Demchenkova
Publikováno v:
Антибиотики и Химиотерапия, Vol 67, Iss 3-4, Pp 46-52 (2022)
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 population, the increasing frequency of polypharmacy, as well as the spread of self-medication, adver
Externí odkaz:
https://doaj.org/article/e91fe3ca73cf43899799cd15ea0fb16c
Autor:
E. V. Shubnikova, T. M. Bukatina, A. A. Druzhinina, E. O. Zhuravleva, G. V. Kutekhova, N. Yu. Velts
Publikováno v:
Безопасность и риск фармакотерапии, Vol 10, Iss 2, Pp 196-199 (2022)
The experts of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on the recalls of antibacterial and antiprotozoal medicinal products and/or the need for labelling up
Externí odkaz:
https://doaj.org/article/a63e51bcbf574109bf86f81a4ec4b204
Publikováno v:
Безопасность и риск фармакотерапии, Vol 10, Iss 1, Pp 19-33 (2022)
The search for an effective and safe COVID-19 therapy involves, among other things, assessment of efficacy of medicines already used for the treatment of other diseases, and having potential antiviral activity against SARS-CoV-2. The relevance of the
Externí odkaz:
https://doaj.org/article/1b15e6f738d9463bab69713906de8cff
Autor:
T. M. Bukatina, E. V. Shubnikova
Publikováno v:
Безопасность и риск фармакотерапии, Vol 10, Iss 1, Pp 6-12 (2022)
The pharmacovigilance system plays one of the key roles in ensuring safety and efficacy of medicine use. The risk management process helps to ensure the most favourable benefit/risk ratio of a medicine or combination of medicines both for the target
Externí odkaz:
https://doaj.org/article/abb2da6596e746f98085ec13e6defd61
Publikováno v:
Безопасность и риск фармакотерапии, Vol 9, Iss 2, Pp 103-105 (2021)
Analysis of administrative decisions of foreign regulatory authorities on the recall of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Cen
Externí odkaz:
https://doaj.org/article/004bd778d7aa43728223c38b54e6c15e