Detection of QTc Effects in Small Studies - Implications for Replacing the Thorough QT Study

Annals of Noninvasive Electrocardiology

Volumn 20, Issue 4, 2015, Pages 368-377

  Ferber, Georg ^a   Zhou, Meijian ^b   Darpo, Borje ^b,c  

^a Statistik Georg Ferber GmbH   (Switzerland)

^b ICARDIAC TECHNOLOGIES INC   (United States)

^c DANDERYD HOSPITAL   (Sweden)

Author keywords

clinical pharmacology; First in Man; ICH E14; QT; QTc; thorough QT study

Indexed keywords

KETOCONAZOLE; LENVATINIB; LOMITAPIDE; MOXIFLOXACIN; PLACEBO; CYTOCHROME P450 3A INHIBITOR; GYRASE INHIBITOR; QUINOLONE DERIVATIVE;

ARTICLE; CONCENTRATION RESPONSE; DRUG BLOOD LEVEL; ELECTROCARDIOGRAM; ELECTROCARDIOGRAPHY MONITORING; FALSE NEGATIVE RESULT; HUMAN; MAXIMUM PLASMA CONCENTRATION; PRIORITY JOURNAL; QTC INTERVAL; SAMPLE SIZE; SINGLE DRUG DOSE; DOSE RESPONSE; DRUG EFFECTS; ELECTROCARDIOGRAPHY; HEART RATE;

CYTOCHROME P-450 CYP3A INHIBITORS; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAPHY; FLUOROQUINOLONES; HEART RATE; HUMANS; KETOCONAZOLE; TOPOISOMERASE II INHIBITORS;

EID: 84937000900     PISSN: 1082720X     EISSN: 1542474X     Source Type: Journal    
DOI: 10.1111/anec.12227     Document Type: Article

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