Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China-Reference-Cited by-同舟云学术

Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China

Published:2022-02-14 Issue:6 Volume:11 Page:734-743
ISSN:2160-763X
Container-title:Clinical Pharmacology in Drug Development
language:en
Short-container-title:Clinical Pharm in Drug Dev

Author:

Wang Fangfang¹²³⁴,Nie Jing⁵,Yang Li⁶,Yang Zhenhua⁷,Xu Lin⁷,Wang Liqun⁵,Liao Huimin⁸,Li Mengyu⁹,Wang Ping⁹,Li Gailing⁵,Li Haiyan¹²³⁴⁷

Affiliation:

1. Department of Cardiology and Institute of Vascular Medicine Peking University Third Hospital Beijing China

2. NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides Peking University Third Hospital Beijing China

3. Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Peking University Third Hospital Beijing China

4. Beijing Key Laboratory of Cardiovascular Receptors Research Peking University Third Hospital Beijing China

5. Janssen China R&D Beijing China

6. Department of Pharmacy Peking University Third Hospital Beijing China

7. Drug Clinical Trial Center Peking University Third Hospital Beijing China

8. Janssen China R&D Shanghai China

9. OTC Medical Affairs, Xian Janssen Pharmaceutical Ltd. Beijing China

Publisher

Wiley

Subject

Pharmacology (medical),Pharmaceutical Science

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpdd.1072

Reference28 articles.

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2. Drug-induced QT interval prolongation: mechanisms and clinical management

3. Assessment of QTc Prolongation for Non-Cardiac-Related Drugs from a Drug Development Perspective

4. Drug-induced prolongation of the QT interval: why the regulatory concern?

5. Scientific white paper on concentration-QTc modeling

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