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Meeting Report: PDA Virus and TSE Safety Forum
PDA Journal of Pharmaceutical Science and Technology, 2013The report provides a summary of the presentations and discussions of the Virus & TSE (transmissible spongiform encephalopathy) Safety Forum 2011 that was organized by the Parenteral Drug Association and held in Barcelona, Spain, on 28-30 June, 2011.
Hannelore, Willkommen +9 more
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B19 Virus Infection and Blood Safety
Journal of Antivirals & Antiretrovirals, 2015Human parvovirus B19 (B19) belongs to the family of parvoviridae and viral particle measures 23 nm in diameter. B19 virus has single-stranded DNA genome and is n non-enveloped virus. It is widespread in the world. The virus can be transmitted via respiratory route and blood-derived products in addition to be transmitted vertically from mother to fetus.
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Safety of live‐virus vaccines for children with immune deficiency
Journal of the American Academy of Nurse Practitioners, 2006AbstractPurpose: Conduct an integrative literature review to evaluate the safety and effectiveness of live‐virus vaccines, namely, the measles, mumps, rubella, and varicella vaccines, in children who are immune compromised by exogenous medication either posttransplant or while undergoing maintenance chemotherapy for leukemia.Data sources: Medline ...
Karlen E, Luthy +3 more
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Problem Solved? West Nile Virus and Transfusion Safety
New England Journal of Medicine, 2005In 2002, just three years after its appearance in the Western Hemisphere, West Nile virus caused the largest outbreak of arboviral encephalitis ever recorded in the United States.1 Epidemiologic investigations that year revealed that West Nile virus could be transmitted by blood transfusion,2 and mathematical models suggested that hundreds of ...
Lyle R, Petersen, Jay S, Epstein
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Clinical evaluation of virus safety and inhibitor incidence
Blood Coagulation & Fibrinolysis, 1995The basic statistical issue in pharmacovigilance is to claim, with reasonable certainty, that the incidence of an event of interest in a population of subjects is less than a certain value. How many subjects and events must be observed before such a claim can be made?
M, Buyse, J L, Poplavsky
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Virus safety of human blood, plasma, and derived products
Thrombosis Research, 2002The reconstitution of blood and its components is hampered by factors of compatibility, availability, and the risk of transmission of infectious diseases. Protozoal agents such as plasmodium malariae and trypanosoma cruzi are only regionally relevant. Bacterial transmissions are easy to prevent and treat.
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Current European Regulations for Control of Adventitious Virus Safety
PDA Journal of Pharmaceutical Science and Technology, 2011CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).
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Postlicensure safety evaluation of human papilloma virus vaccines
International Journal of Risk & Safety in Medicine, 2011Objective: A summary of postlicensure safety information of HPV vaccines from three sources: VigiBase, the global database of WHO's Programme for International Drug Monitoring, the VAERS report on Gardasil® and the RIVM report on Cervarix®. Method: all AEFI from the three sources were recalculated to a percentage of all AEFI reported for each of the ...
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