Evaluating the Use of Linear Mixed‐Effect Models for Inference of the Concentration‐QTc Slope Estimate as a Surrogate for a Biological QTc Model

Author:

Huh Y1,Hutmacher MM1

Affiliation:

1. Ann Arbor Pharmacometrics Group (A2PG) IncAnn Arbor Michigan USA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Reference22 articles.

1. Drug-Induced Torsades de Pointes and Implications for Drug Development

2. Guidance on E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non‐antiarrhythmic drugs; availability. Notice;International Conference on Harmonisation;Fed. Regist.,2005

3. Population Pharmacokinetic and Concentration-QTc Models for Moxifloxacin: Pooled Analysis of 20 Thorough QT Studies

4. New confidence bounds for QT studies

5. Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance

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