Assessing QT/QTc interval prolongation with concentration-QT modeling for Phase I studies: impact of computational platforms, model structures and confidence interval calculation methods-Reference-Cited by-同舟云学术

Assessing QT/QTc interval prolongation with concentration-QT modeling for Phase I studies: impact of computational platforms, model structures and confidence interval calculation methods

Published:2018-03-19 Issue:3 Volume:45 Page:469-482
ISSN:1567-567X
Container-title:Journal of Pharmacokinetics and Pharmacodynamics
language:en
Short-container-title:J Pharmacokinet Pharmacodyn

Author:

Lu Jingtao,Li Jianguo,Helmlinger Gabriel,Al-Huniti Nidal

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

http://link.springer.com/article/10.1007/s10928-018-9582-0/fulltext.html

Reference45 articles.

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2. Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N (2015) Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase. Clin Pharmacol Ther 97(4):326–335. https://doi.org/10.1002/cpt.60

3. Darpo B, Sarapa N, Garnett C, Benson C, Dota C, Ferber G, Jarugula V, Johannesen L, Keirns J, Krudys K, Ortemann-Renon C, Riley S, Rogers-Subramaniam D, Stockbridge N (2014) The IQ-CSRC prospective clinical phase 1 study: “can early QT assessment using exposure response analysis replace the thorough QT study?”. Ann Noninvasive Electrocardiol 19(1):70–81. https://doi.org/10.1111/anec.12128

4. Garnett C, Needleman K, Liu J, Brundage R, Wang Y (2016) Operational characteristics of linear concentration-QT models for assessing QTc interval in the thorough QT and phase I clinical studies. Clin Pharmacol Ther 100(2):170–178. https://doi.org/10.1002/cpt.361

5. Garnett CE, Beasley N, Bhattaram VA, Jadhav PR, Madabushi R, Stockbridge N, Tornoe CW, Wang Y, Zhu H, Gobburu JV (2008) Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol 48(1):13–18. https://doi.org/10.1177/0091270007307881

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2. Impact of Phase 1 study design on estimation of QT interval prolongation risk using exposure–response analysis;Journal of Pharmacokinetics and Pharmacodynamics;2019-10-29

3. Thorough QT/QTc in a Dish: An In Vitro Human Model That Accurately Predicts Clinical Concentration‐QTc Relationships;Clinical Pharmacology & Therapeutics;2018-12-02