Predictions about probabilities of adverse events and appropriate dose of roflumilast for Chinese CO

来源 :第五届定量药理学与新药评价国际会议 | 被引量 : 0次 | 上传用户:goodcareer
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Backgrounds: Roflumilast is an oral inhibitor of phosphodiesterase 4(PDE4), which is mainly metabolized by CYP3A4 and CYP1A2.The main metabolite of it is roflumilast N-oxide, which contributes to the efficacy largely.While it has been proved that the abundance of CYP1A2 demonstrated a significant difference between Chinese and Caucasian, which may lead to a significant difference of exposure between Chinese and Caucasian.In addition, it has been shown a very difference adverse event (AE) profile of roflumilast among Chinese COPD patients from that among Caucasian COPD patients.Objects: This essay is aimed to predict AE probabilities and appropriate dose of roflumilast for Chinese COPD patients based on physiologically-based pharmacokinetic (PBPK) model and population pharmacokinetic (PopPK) models.
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