IN VITRO ELECTROPHYSIOLOGY SAFETY STUDIES (hERG)
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چکیده
ICH S7B guideline regulates the in vitro IKr assay in combination with in vivo QT evaluation prior to first-in-human administration. This guideline has been recommended for adoption by the regulatory bodies of 3 regions (Japan, USA and EU). To support compound development through cardiovascular safety assessment, Charles River Preclinical Services, Edinburgh (PCS-EDI) has developed and operates an in vitro electrophysiology capability in accordance with the ICH S7B guideline so that we can continue to offer and support our clients with a full package of safety pharmacology studies.
منابع مشابه
Improving the In Silico Assessment of Proarrhythmia Risk by Combining hERG (Human Ether-à-go-go-Related Gene) Channel-Drug Binding Kinetics and Multichannel Pharmacology.
BACKGROUND The current proarrhythmia safety testing paradigm, although highly efficient in preventing new torsadogenic drugs from entering the market, has important limitations that can restrict the development and use of valuable new therapeutics. The CiPA (Comprehensive in vitro Proarrhythmia Assay) proposes to overcome these limitations by evaluating drug effects on multiple cardiac ion chan...
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Sudden cardiac death secondary to drug-induced long QT syndrome is a major safety concern and has led to withdrawal of several high-profile drugs, such as cisapride and astemizole, from the market. Although these drugs have different chemical structures, they all block the rapid delayed rectifier K current (I Kr ) with high potency. The hERG channel (Kv11.1) encoded by the hERG gene is responsi...
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