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...

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Detalhes bibliográficos
Main Authors: Nishimura, Tsutomu, Tada, Harue, Nakagawa, Masatsugu, Teramukai, Satoshi, Matsui, Shigeyuki, Fukushima, Masanori
Formato: Artigo
Idioma:Inglês
Publicado em: Centro de Investigaciones y Publicaciones Farmaceuticas 2006
Assuntos:
Original Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4155619/
https://ncbi.nlm.nih.gov/pubmed/25214906
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