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Pharmacovigilance: An Overview [PDF]
Clinical Therapeutics, 2018 Pharmacovigilance (PV) is a relatively new discipline in the pharmaceutical industry. Having undergone rapid growth over the past 2 decades, PV now touches many other disciplines in the research and development enterprise. With its growth has come a heightened awareness and interest in the medical community about the roles that PV plays.
Paul Beninger
exaly +3 more sources
Pharmacovigilance system in Saudi Arabia
Saudi Pharmaceutical Journal, 2017 Pharmacovigilance plays an important role in ensuring that patients are receiving safe drugs. In Saudi Arabia, Saudi Food and Drug Authority, health institutions, marketing authorization holders and healthcare professional are involved in ...
Thamir M Alshammari +2 more
exaly +3 more sources
Organisation of the Russian Pharmacovigilance System: Survey of Pharmacovigilance Officers
Безопасность и риск фармакотерапии, 2021 Ensuring the safety of pharmacotherapy is a priority of the national regulatory health policy and is enshrined in the international and federal legislation.
A. E. Krasheninnikov +2 more
doaj +1 more source
Frontiers in Immunology, 2023 BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce ...
Janneke W. Duijster +8 more
doaj +1 more source
BMC Infectious Diseases, 2021 Background Norovirus is an important cause of acute gastroenteritis globally. However, norovirus is rarely laboratory confirmed or recorded explicitly as a cause of hospitalization.
Elsa Negro-Calduch +2 more
doaj +1 more source
Audits and inspections of pharmacovigilance systems in Russia
Качественная клиническая практика, 2023 The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as ...
A. A. Taube, B. K. Romanov
doaj +1 more source
Research Progress of Antitumor Pharmacovigilance
Chinese Journal of Lung Cancer, 2022 In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released.
Wenjuan SUN, Yang HU, Yan XU, Bo ZHANG
doaj +1 more source
Suvorexant (Belsomra® Tablets 10, 15, and 20 mg): Japanese Drug-Use Results Survey
Drugs in R&D, 2018 Background We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra®) tablets. Methods A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were ...
Yuko Asai +5 more
doaj +1 more source
Pharmacovigilance in oncology [PDF]
International Journal of Clinical Pharmacy, 2018 AbstractBackground Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow ...
Paolo Baldo +4 more
openaire +2 more sources
Infectious Diseases and Therapy, 2023 Introduction Molnupiravir is an oral antiviral drug that received special approval for emergency use in Japan on December 24 2021 for infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Masahiro Kimata +4 more
doaj +1 more source