Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review

Journal of Clinical Pharmacology

Volumn 48, Issue 1, 2008, Pages 13-18

  Garnett, Christine E ^a   Beasley, Nhi ^a   Atul Bhattaram, V ^a   Jadhav, Pravin R ^a   Madabushi, Rajanikanth ^a   Stockbridge, Norman ^a   Tornøe, Christoffer W ^a   Yaning Wang, ^a   Hao Zhu, ^a   Gobburu, Jogarao V ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

ICH E14; Modeling; Pharmacodynamics; Pharmacokinetics; QT interval

Indexed keywords

LAPATINIB; MOXIFLOXACIN; RANOLAZINE;

ADVANCED CANCER; ANGINA PECTORIS; CARDIOVASCULAR RISK; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG LABELING; DRUG SAFETY; ELECTROCARDIOGRAPHY MONITORING; HEART PROARRHYTHMIA; HUMAN; LIVER DISEASE; LIVER FAILURE; PLANNING; PRACTICE GUIDELINE; QT INTERVAL; QT PROLONGATION; REVIEW; RISK ASSESSMENT; SIDE EFFECT;

ARRHYTHMIAS, CARDIAC; CLINICAL TRIALS AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, INVESTIGATIONAL; GUIDELINES AS TOPIC; HUMANS; LONG QT SYNDROME; RISK ASSESSMENT; RISK FACTORS;

EID: 37349079996     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007307881     Document Type: Review

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