QT Assessment in Early Clinical Development Can the Predictive Value be Enhanced to be Similar to That of a TQT study?
Posted:
15
January 2012
QT Assessment in Early Clinical Development Can the Predictive Value be Enhanced to be Similar to That of a TQT study?
Following the JCP Nov 2011 publication proposing food as a viable means for demonstrating assay sensitivity for ECG assessment in clinical trials, this is now proposed alongside other potential methods at the upcoming CSRC ThinkTank meeting on QT Assessment in Early Clinical Development being held 2 Feb at the FDA Headquarters in Silver Spring.The purpose of these meetings is the formation of collaborative CSRC research groups with members from regulators, sponsors and academia with the goal to perform, promote and compile research in areas addressing identified key knowledge gaps.
Futureproofing early phase clinical research for the next generation of investigators.
March 20, 2023
Richmond Pharmacology’s experienced Principal investigators and Co-investigators recently gave expert feedback on the ICH M11 (CeSHarP) protocol template.
13th International Workshop on Regulatory Requirements and Current Scientific Aspects on the Preclinical and Clinical Investigation of Drug-Drug Interactions
Sunday, June 4th to Tuesday June 6th 2023
Exchange research-based knowledge on drug-drug interactions (DDIs) among all interested stakeholders from pharmaceutical industry, regulatory authorities, academic and health care delivery backgrounds and perspectives.
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