Drug-induced prolongation of the QT interval: regulatory dilemmas and implications for approval and labelling of a new chemical entity.
Shah
Rashmi R
RR
Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London, UK.
D000075202:Contraindications; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical; D004347:Drug Interactions; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D062787:Drug Overdose; D015507:Drugs, Investigational / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced*
D015507:Drugs, Investigational