Establishing in vitro to clinical correlations in the evaluation of cardiovascular safety pharmacology.
Preclinical studies are vital in establishing the efficacy and safety of a new chemical entity (NCE) in humans. To deliver meaningful information, experiments have to be well defined and provide outcome that is relevant and translatable to humans. This review briefly surveys the various preclinical experiments that are frequently conducted to assess drug effects on cardiac conductivity in early drug development. We examine the different approaches used to establish correlations between non-clinical and clinical settings and discuss their value in the evaluation of cardiovascular risk.
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Chain
M C J M
MC
Sturkenboom
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M
Danhof
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OE
Della Pasqua
D000818:Animals; D002319:Cardiovascular System / Q000187:drug effects*; D004353:Drug Evaluation, Preclinical; D015507:Drugs, Investigational / Q000009:adverse effects*; D006801:Humans; D010601:Pharmacology, Clinical; D057170:Translational Research, Biomedical
D015507:Drugs, Investigational