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体外代谢

ADME 测定开发流程包括体外 ADME 测定,一旦选择了主要候选物,就需要进行这些分析。候选药物的安全性特征将部分取决于其与其他药物的相互作用,特别是可能伴随使用的标准治疗的药物。因此,使用经验证的生物分析方法评估可能的药物相互作用风险是候选物开发过程中的重要早期步骤。Q2 Solutions 提供一组体外测定以支持药物间相互作用检测,包括细胞色素 P450(CYP)酶抑制(IC50)、时间依赖性 CYP 抑制、CYP 酶诱导和 CYP 反应表型分析。所有体外代谢测定结果均以 QC 审查、监管风格报告的形式呈现,以支持 IND 申请的申报。

评估药物间相互作用风险

药物相互作用检测对这些风险进行了明确的评估,该检测应在选择主要候选物后尽早进行

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