QT Prolongation Risk Assessment in Oncology: Lessons Learned From Small‐Molecule New Drug Applications Approved During 2011‐2019-Reference-Cited by-同舟云学术

QT Prolongation Risk Assessment in Oncology: Lessons Learned From Small‐Molecule New Drug Applications Approved During 2011‐2019

Published:2021-04-12 Issue: Volume: Page:
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Cohen‐Rabbie Sarit¹,Berges Alienor C.¹,Rekić Dinko²,Parkinson Joanna²,Dota Corina³,Tomkinson Helen K.¹

Affiliation:

1. Clinical Pharmacology and Quantitative Pharmacology Clinical Pharmacology and Safety Science, AstraZeneca BioPharmaceuticals R&D Cambridge UK

2. Clinical Pharmacology and Quantitative Pharmacology Clinical Pharmacology and Safety Science BioPharmaceuticals R&D Gothenburg Sweden

3. Patient Safety Center of Excellence Oncology R&D Gothenburg Sweden

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1844

Reference24 articles.

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3. Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non‐Antiarrhythmic Drugs. Issued by: Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. 2005.https://www.fda.gov/media/71372/download. Accessed January 25 2020.

4. Prolonged QTc Interval in Cancer Therapeutic Drug Development: Defining Arrhythmic Risk in Malignancy

5. QTc prolongation and/or oncology drug development: who's in danger?;Jonge M;Eur J Cancer,2008

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