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A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors

We compared and determined the reasons for any differences in the review and approval times of tyrosine kinase inhibitors (TKIs) by the US Food and Drug Administration (FDA) and the European EMA/CHMP. Applications for these novel cancer drugs were submitted to them within a mean of 31.2 days of each...

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Detaylı Bibliyografya
Asıl Yazarlar: Shah, Rashmi R, Roberts, Samantha A, Shah, Devron R
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: Blackwell Science Inc 2013
Konular:
Online Erişim:https://ncbi.nlm.nih.gov/pmc/articles/PMC3769667/
https://ncbi.nlm.nih.gov/pubmed/23362829
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.12085
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