Concentration‐QT modelling in early clinical oncology settings: Simulation evaluation of performance-Reference-Cited by-同舟云学术

Concentration‐QT modelling in early clinical oncology settings: Simulation evaluation of performance

Published:2021-09-09 Issue: Volume: Page:
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Cantet Gael¹,Berges Alienor¹²,O'Sullivan Rhianna¹,Cohen‐Rabbie Sarit¹,Dota Corina³,Dubois Vincent¹,Benoist Guillemette E.⁴,Tomkinson Helen¹,Rekić Dinko⁵,Parkinson Joanna⁵^ORCID,Schalkwijk Stein¹²^ORCID

Affiliation:

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

2. Clinical Pharmacology Modelling and Simulation GlaxoSmithKline UK

3. Cardiovascular Safety Centre of Excellence, CMO Oncology R&D Gothenburg Sweden

4. Department of Pharmacy Radboud University Medical Center Nijmegen Netherlands

5. Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D AstraZeneca Gothenburg Sweden

Funder

AstraZeneca Pharma Poland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15047

Reference22 articles.

1. ICH Expert Working Group.The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non‐Antiarrhythmic Drugs E14.https://database.ich.org/sites/default/files/E14_Guideline.pdf. Accessed January 4 2021.

2. Cardiac Safety Research Consortium: Can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward

3. ICH Expert Working GroupInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use E14 Implementation Working Group ICH E14 Guideline: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non‐Antiarrhythmic Drugs Questions & Answers (R3). 2016.https://database.ich.org/sites/default/files/E14_Q%26As_R3_Q%26As.pdf. Accessed January 4 2021.

4. QT Assessment in Early Drug Development: The Long and the Short of It

5. Scientific white paper on concentration-QTc modeling

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