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。

This paper sums up the key points of quality control in reproductive and developmental toxicity studies from five aspects, such as experiment preparation, test operation, original data records compilation, and summary reports writing: ① designing scientific and reasonable experimental schemes and record forms; ② collecting the background data of experimental animals; ③ establishing uniform standards for experimental operations and detection indexes; ④ maintaining the original data records in an orderly manner and retaining for a specified period; ⑤ writing summary reports carefully and meticulously.