Comparison of electrocardiogram and blood pressure recording methods in non-rodent toxicology studies: A retrospective analysis

Author:

Pawluk Emma,Delaunois Annie,Gamboa Bastien,Valentin Jean-Pierre

Publisher

Elsevier BV

Reference49 articles.

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2. Anonymous. (1997). ICH Guideline S6(R1) – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. EMA/CHMP/ICH/731268/1998. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals-step-5_en.pdf.

3. Anonymous. (1998). ICH Topic S4: Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) CPMP/ICH/300/95. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-4-duration-chronic-toxicity-testing-animals-rodent-and-non-rodent-toxicity-testing-step-5_en.pdf.

4. Anonymous. (2000). ICH Topic S7A: Safety Pharmacology Studies for Human Pharmaceuticals. CPMP/ICH/539/00. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-7-safety-pharmacology-studies-human-pharmaceuticals-step-5_en.pdf.

5. Anonymous (2005a). ICH Topic E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. CHMP/ICH/2/04. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-14-clinical-evaluation-qtqts-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic-drugs-step-5_en.pdf.

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1. Innovative approaches to cardiovascular safety pharmacology assessment;Journal of Pharmacological and Toxicological Methods;2024-07

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