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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 study on the possible adverse reactions of human beings after exposure to drugs, including drug hazard identification, dose-response relationship assessment, drug exposure assessment and drug risk characterization. An important and challenging job. With the application of the model of biological mechanism in the assessment of drug risk, the rapid development of biomarker and its effectiveness evaluation, the extensive use of bioinformatics, toxicology on silicon, and toxicology and other studies, the use of animal models instead Risk assessment of the human body is becoming more and more possible.