论文部分内容阅读
药品的“安全、有效、可控”是中药新药开发中三个最基本,也是最重要的前提,三者缺一不可。GLP是药品临床前研究重要的质量保证体系。CLP要求对临床前药品安全性评价所涉及的各个方面用语言简洁、明确的指令性书面文件系统进行规范,使整个过程有章可循,做到标准化、规范化。这个文件系统必须具有科学性、合理性、可操作性,并要求有极高的重现性和稳定性。因此,科学地编制和认真地执行GLP文件系统,是提高中药新药非临床研究质量、保证实验资料真实、可靠,保障人民群众用药安全的重要步骤。
The “safe, effective, and controllable” drugs are the three most basic and important prerequisites for the development of new Chinese medicines. The three are indispensable. GLP is an important quality assurance system for preclinical research in medicine. The CLP requires that all aspects involved in preclinical drug safety evaluations be regulated by a concise language and clear prescriptive written document system, so that the entire process can be followed in a ruled manner and standardized and standardized. This file system must be scientific, reasonable, operational, and require extremely high reproducibility and stability. Therefore, scientifically compiling and seriously implementing the GLP file system is an important step in improving the quality of non-clinical research of new Chinese medicines, ensuring the authenticity and reliability of experimental data, and ensuring the safety of people’s medication.