Replacing the thorough QT study: reflections of a baby in the bath water
Author:
Affiliation:
1. eResearch Technology; Philadelphia PA USA
2. Rashmi Shah Consultancy Ltd; Gerrards Cross Bucks UK
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1111/bcp.12296/fullpdf
Reference40 articles.
1. Health Canada Draft guidance ‘Assessment of the QT prolongation potential of non-antiarrhythmic drugs 2001
2. Cardiac repolarisation and drug regulation: assessing cardiac safety 10 years after the CPMP guidance;Shah;Drug Saf,2007
3. Evolution of the thorough QT study;Wheeler;Regul Rapporteur,2010
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