A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.
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Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014Cardiovascular safety of tyrosine kinase inhibitors: with a special focus on cardiac repolarisation (QT interval).Effect of tyrosine kinase inhibitors on wound healing and tissue repair: implications for surgery in cancer patients.Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit.Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?Do the EMA accelerated assessment procedure and the FDA priority review ensure a therapeutic added value? 2006-2015: a cohort study.Tyrosine Kinase Inhibitor-Induced Interstitial Lung Disease: Clinical Features, Diagnostic Challenges, and Therapeutic Dilemmas.Use of the conditional marketing authorization pathway for oncology medicines in Europe.Cancer therapeutics revisited; novel drugs targeting cell signalling pathways, genome wide association studies and other trials and tribulations.How do we avoid disaster when exiting the European Medicines Agency? Making the most of Brexit in pharmaceutical regulation.In response to Alqahtani et al. (2015 Jul; 24(7):709-15): suggesting an international regulatory harmonization for priority review drugs need further investigations.
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A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.
description
article científic
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article scientifique
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articolo scientifico
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artigo científico
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bilimsel makale
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scientific article published on September 2013
@en
vedecký článok
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vetenskaplig artikel
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videnskabelig artikel
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vědecký článek
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name
A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
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A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
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type
label
A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
@en
A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
@nl
prefLabel
A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
@en
A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
@nl
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P2860
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A fresh perspective on compari ...... ic tyrosine kinase inhibitors.
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Devron R Shah
Rashmi R Shah
Samantha A Roberts
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P304
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10.1111/BCP.12085
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P577
2013-09-01T00:00:00Z