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根据实践工作经验,从试验人员的角度,就试验前准备、试验实施、原始资料整理及总结报告撰写等方面总结了药物非临床生殖发育毒性试验的质量控制要点:1制定科学合理的实验方案和记录表格;2建立完善的实验动物背景数据资料库;3制定标准统一的各项试验操作和检测指标;4妥善整理并保存各类原始资料;5严谨细致撰写总结报告。
According to the practical working experience, the quality control points of the non-clinical reproductive and developmental toxicity test of drug are summed up from the perspective of the experimenter on preparation of pre-test, implementation of test, compilation of original data and compilation of summary report. 1. To develop scientific and reasonable experimental plan and Record the form; 2 establish a sound background database of experimental animals; 3 develop a unified standard of test operations and testing indicators; 4 properly organize and save all kinds of raw materials; 5 rigorous meticulous writing summary report.