| アブストラクト | In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment. |
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| ジャーナル名 | The Lancet. Oncology |
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| Pubmed追加日 | 2016/11/8 |
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| 投稿者 | Pitts, Peter J; Louet, Herve Le; Moride, Yola; Conti, Rena M |
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| 組織名 | Center for Medicine in the Public Interest, New York, NY, USA; Ecole Superieure;des Sciences Economiques et Commerciales, Paris, France; Ecole Superieure des;Sciences Economiques et Commerciales, Singapore. Electronic address:;ppitts@cmpi.org.;Pharmacovigilance Department, Henri Mondor/Assistance Publique Hopitaux de Paris;Universite Paris est Creteil, Paris, France; International Society of;Pharmacovigilance, Creteil, France.;Faculty of Pharmacy, Universite de Montreal, Montreal, QC, Canada; International;Society of Pharmacovigilance, Creteil, France.;Health Economics and Policy Departments of Pediatrics Hematology/Oncology and;Public Health Sciences, University of Chicago, Chicago, IL, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27819246/ |
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