A Framework Proposal to Follow‐Up on Preclinical Convulsive Signals of a New Molecular Entity in First‐in‐Human Studies Using Electroencephalographic Monitoring-Reference-Cited by-同舟云学术

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A Framework Proposal to Follow‐Up on Preclinical Convulsive Signals of a New Molecular Entity in First‐in‐Human Studies Using Electroencephalographic Monitoring

Published:2019-05-31 Issue:5 Volume:106 Page:968-980
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Abt Markus¹,Dinklo Theo²,Rothfuss Andreas²,Husar Elisabeth²,Dannecker Robert³,Kallivroussis Katja⁴,Peck Richard²,Doessegger Lucette⁵,Wandel Christoph⁶

Affiliation:

1. Department of BiometricsF. Hoffmann‐La Roche AG Basel Switzerland

2. Roche Pharma Research and Early DevelopmentRoche Innovation Center BaselF. Hoffmann‐La Roche AG Basel Switzerland

3. Consultant Pharmacokinetics Lucerne Switzerland

4. Consultant Toxicology Basel Switzerland

5. Consultant Toxicology & Clinical Safety Zürich Switzerland

6. Department of Safety & Risk ManagementF. Hoffmann‐La Roche AG Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1455

Reference68 articles.

1. A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans

2. Origins, practices and future of safety pharmacology

3. Telemetry video-electroencephalography (EEG) in rats, dogs and non-human primates: Methods in follow-up safety pharmacology seizure liability assessments

4. Safety pharmacology investigations on the nervous system: An industry survey

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Comparative sensitivity of laboratory animals used for preclinical convulsion risk assessment to drug-induced convulsion;The Journal of Toxicological Sciences;2024

2. Current state of and challenges in in vivo central nervous system evaluation in safety pharmacology studies—Topic overview and initiatives of the Japanese Safety Pharmacology Society;Folia Pharmacologica Japonica;2021

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