Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates

Journal of Clinical Pharmacology

Volumn 48, Issue 1, 2008, Pages 6-8

  Bloomfield, Daniel ^a   Krishna, Rajesh ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Concentration response; Drug effect; ICH E14; Modeling; PK PD; QT interval; Simulation

Indexed keywords

NEW DRUG;

DRUG DOSE COMPARISON; DRUG SAFETY; ELECTROCARDIOGRAPHY MONITORING; HEART REPOLARIZATION; HUMAN; NOTE; PRACTICE GUIDELINE; QT INTERVAL; QT PROLONGATION;

CARDIOVASCULAR AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, INVESTIGATIONAL; GUIDELINES AS TOPIC; HUMANS; LONG QT SYNDROME; RISK ASSESSMENT;

EID: 37349064915     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270007312257     Document Type: Note

References (2)

1. ICH E14 guidence: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Federal Register. 2005 ; 70 (202). 61134-61135.
2. Gobburu J. PKPD Modeling Can Be Used in Lieu of the Endpoint Definition in ICH E14. Paper presented at: Drug Information Association, Food and Drug Administration, Heart Rhythm Society Symposium QT Issues in Drug Development: the evolving science, practical issues, and regulatory implications ; April 12, 2007 ; Washington, DC.