Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver-Reference-Cited by-同舟云学术

Application of Trial Simulation in the Design of a Prospective Study for Concentration-QTc Analysis in Support of a Thorough QT Study Waiver

Published:2020-08-02 Issue:5 Volume:22 Page:
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Zhu Peijuan^ORCID,Hsu Chyi-Hung,Hu Chuanpu,Wong Peggy,Sy Sherwin K. B.,Nandy Partha,Zhou Honghui

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

https://link.springer.com/content/pdf/10.1208/s12248-020-00488-3.pdf

Reference24 articles.

1. Research C for DE and. E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for Industry [Internet]. US Food Drug Adm. 2019 [cited 2020 Jan 24]. Available from: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/e14-clinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic-1

2. Darpo B, Garnett C, Keirns J, Stockbridge N. Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14. Drug Saf [Internet]. 2015 [cited 2019 Jul 15];38:773–80. Available from: https://doi.org/10.1007/s40264-015-0325-5

3. Ferber G. Data-based simulation studies to assess the power of detecting moxifloxacin QTc response using concentration-QTc in small phase-1 studies [Internet]. 2011. Available from: https://cardiac-safety.org/wp-content/uploads/2014/11/Ferber-Washington-2012.pdf

4. The IQ-CSRC Prospective Clinical Phase 1 Study: “Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?” - Darpo - 2014 - Annals of Noninvasive Electrocardiology - Wiley Online Library [Internet]. [cited 2019 Jul 15]. Available from: https://doi.org/10.1111/anec.12128

5. Results From the IQ-CSRC Prospective Study Support Replacement of the Thorough QT Study by QT Assessment in the Early Clinical Phase - Darpo - 2015 - Clinical Pharmacology & Therapeutics - Wiley Online Library. [cited 2019 Jul 15]; Available from: https://doi.org/10.1002/cpt.60

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