根據(jù)實踐工作經(jīng)驗,從試驗人員的角度,就試驗前準備、試驗實施、原始資料整理及總結(jié)報告撰寫等方面總結(jié)了藥物非臨床生殖發(fā)育毒性試驗的質(zhì)量控制要點;①制定科學合理的實驗方案和記錄表格;②建立完善的實驗動物背景數(shù)據(jù)資料庫;③制定標準統(tǒng)一的各項試驗操作和檢測指標;④妥善整理并保存各類原始資料;⑤嚴謹細致撰寫總結(jié)報告。

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.