药物危险度评估策略及展望

Strategies and prospects of drug risk assessment

药物危险度评估是对人类暴露于药物后可能造成的身体不良反应的系统科学研究,包括药物危险鉴定、剂量-反应关系评定、药物暴露评估和药物危险度特征判定4个步骤,是一复杂又具有重要意义的挑战性工作。随着药物危险度评估中生物学机制模型的应用,生物标志物及其有效性评价工作的迅速开展,生物信息学、硅上毒理学、毒理组学等研究的广泛深入,使用动物模型替代人体进行危险度评估越来越成为可能。

Drug risk assessment is a systematic and scientific evaluation of potential adverse effects resulting from human exposures to drugs, including identification of drug risk, assessment of dose-response relationship, exposure assessment, and risk characteristics. It is a complex and significant challenging work. Accompanied by the extensive studies of bioinformatics, in silico toxicology and toxicological omics, the biological mechanism models have been used ; rapid assessments of biomarkers and their effectiveness have been carried out. Thus it has become increasingly possible to use animal models instead of human bodies in risk assessment.