Medical Letter on the CDC & FDA
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Pharmacology
New pharmacology data have been reported by scientists at Medicines and Healthcare products Regulatory Agency
November 9th, 2008
A report, 'If a drug deemed 'safe' in nonclinical tests subsequently prolongs QT in phase 1 studies, how can its sponsor convince regulators to allow development to proceed,' is newly published data in Pharmacology and Therapeutics. According to recent research from London, the United Kingdom, "New drugs are now routinely investigated for their QT-liability in nonclinical studies as well as in a formal Thorough QT Study in man. Data from these studies in man have provided better evidence of the benefits of defining concentration-QT effect relationship of a drug." "Therefore, sponsors also frequently monitor electrocardiograms in early phase I clinical...
Source: Medical Letter on the CDC & FDA (2008-11-09)
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