Evaluating the Use of Linear Mixed‐Effect Models for Inference of the Concentration‐QTc Slope Estimate as a Surrogate for a Biological QTc Model-Reference-Cited by-同舟云学术

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

Published:2015-01 Issue:1 Volume:4 Page:1-9
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Huh Y¹,Hutmacher MM¹

Affiliation:

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

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.14

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

Cited by 15 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Concentration‐QTc Modeling of the DPP‐4 Inhibitor HSK7653 in a First‐in‐Human Study of Chinese Healthy Volunteers;Clinical Pharmacology in Drug Development;2024-05-17

2. Concentration–QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia;Cancer Chemotherapy and Pharmacology;2021-01-08

3. Novel concentration‐QTc models for early clinical studies with parallel placebo controls: A simulation study;Pharmaceutical Statistics;2020-12-08

4. Evaluation of the Effect of Contezolid (MRX-I) on the Corrected QT Interval in a Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study in Healthy Chinese Volunteers;Antimicrobial Agents and Chemotherapy;2020-05-21

5. Evaluation of QT Liability for PF‐05251749 in the Presence of Potential Circadian Rhythm Modification;CPT: Pharmacometrics & Systems Pharmacology;2019-12-25