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Lessons from gefitinib-induced interstitial lung disease in Japan: Problems in approval, pharmacovigilance, and regulatory decision-making procedures
OBJECTIVE: The objective of this study was to identify problems in the approval, pharmacovigilance, and post-approval regulatory decision-making procedures involving gefitinib and to propose countermeasures to prevent further drug-induced suffering in Japan in the future. METHODS: We comprehensively...
Autores principales: | Nishimura, Tsutomu, Tada, Harue, Nakagawa, Masatsugu, Teramukai, Satoshi, Matsui, Shigeyuki, Fukushima, Masanori |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Centro de Investigaciones y Publicaciones Farmaceuticas
2006
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4155619/ https://www.ncbi.nlm.nih.gov/pubmed/25214906 |
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