Incorporating Exposure-Response Modeling Into the Assessment of QTc Interval: A Potential Alternative to the Thorough QT Study

Clinical Pharmacology and Therapeutics

Volumn 97, Issue 5, 2015, Pages 444-446

  Bloomfield, D M ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARDIOVASCULAR AGENT;

DRUG EFFECTS; ELECTROCARDIOGRAPHY; FEMALE; HUMAN; LONG QT SYNDROME; MALE;

CARDIOVASCULAR AGENTS; ELECTROCARDIOGRAPHY; FEMALE; HUMANS; LONG QT SYNDROME; MALE;

EID: 84930988888     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/CPT.92     Document Type: Article

References (7)

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3. ICH E14r2 Q&A on concentration-response analysis. Question 5 page 11.
4. Darpo et al. Clin. Pharmacol. Ther. XX, XXX– XXX (2015).
5. Chapel, S., Hutmacher, M.M., Bockbrader, H., de Greef, R. & Lalonde, R.L. Comparison of QTc data analysis methods recommended by the ICH E14 guidance and exposure-response analysis: case study of a thorough QT study of asenapine. Clin. Pharmacol. Ther. 89, 75–80 (2011).
6. Bloomfield, D.M. et al. A thorough QTc study to assess the effect of sitagliptin, a DPP4 inhibitor, on ventricular repolarization in healthy subjects. J. Clin. Pharmacol. 49, 937–946 (2009).
7. Sitagliptin [prescribing information]. Whitehouse Station, NJ: Merck and Co. .