Drug-induced prolongation of the QT interval: Regulatory dilemmas and implications for approval and labelling of a new chemical entity

Fundamental and Clinical Pharmacology

Volumn 16, Issue 2, 2002, Pages 147-156

  Shah, Rashmi R ^a  

^a MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

Author keywords

Labelling; New chemical entities; QT interval; Regulatory approval; Risk benefit; Torsade de pointes

Indexed keywords

ANTIANGINA PECTORIS AGENT; ANTIARRHYTHMIC AGENT; ASTEMIZOLE; AZIMILIDE; CISAPRIDE; DIURETIC AGENT; DOFETILIDE; NEUROLEPTIC AGENT; NORASTEMIZOLE; PIMOZIDE; SERTINDOLE; SOTALOL; SPARFLOXACIN; TERODILINE; THIORIDAZINE; NEW DRUG;

CONFERENCE PAPER; DRUG CONTRAINDICATION; DRUG DOSE; DRUG EFFECT; DRUG MECHANISM; ELECTROCARDIOGRAM; EVALUATION; HEART ELECTROPHYSIOLOGY; HEART REPOLARIZATION; HUMAN; NONHUMAN; PRIORITY JOURNAL; PUBLIC HEALTH; QT INTERVAL; RISK ASSESSMENT; RISK FACTOR; ARTICLE; CHEMICALLY INDUCED DISORDER; DRUG APPROVAL; DRUG INTERACTION; DRUG LABELING; DRUG SCREENING; INTOXICATION; LEGAL ASPECT; LONG QT SYNDROME;

DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUG INTERACTIONS; DRUG LABELING; DRUGS, INVESTIGATIONAL; HUMAN; LONG QT SYNDROME; OVERDOSE; HUMANS;

EID: 0035985144     PISSN: 07673981     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1472-8206.2002.00083.x     Document Type: Conference Paper

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