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安全、有效、可控是新药研究开发中需要明确的三个基本问题,其中临床前安全性评价是决定新药能否进入临床试验的关键因素之一。临床前安全性评价的目的是提供新药对人类健康危害程度的科学依据,预测上市新药对人类健康的危害程度。临床前安全性评价研究的质量直接关系到人民用药的安全,GLP的建立就是为了确保实验资料的真实、完整和可靠。保障人民的用药安全。本文将对GLP的发展情况和动向进行论述。
Safe, effective and controllable are the three basic problems that need to be clearly defined in the research and development of new drugs. The preclinical safety evaluation is one of the key factors to determine whether a new drug can enter clinical trials. The purpose of preclinical safety assessment is to provide a scientific basis for the degree of harm to human health caused by new drugs and to predict the degree of harm to human health caused by new drugs marketed. The quality of preclinical safety evaluation research is directly related to the safety of people’s medication. The establishment of GLP is to ensure the authenticity, integrity and reliability of experimental data. To protect people’s drug safety. This article will discuss the development and trends of GLP.