Page 61 - 实用英语手册电子书

18. Is generally a stability result that does not follow the expected trend, either in comparison
with other stability batches or with respect to previous results collected during a stabilit study.
The result is not necessarily OOS but does not look like a typical data point.
超趋势数据（OOT）：通常指的是不符合预期趋势的稳定性数据，或者是与其他稳定性批
次或本批次前期考察的稳定性数据相比不符合趋势，在合格范围内但超过历史波动范围或
变化趋势的数据。

19. Results that are still within specification but are unexpected, questionable, irregular, deviant
or abnormal. Examples would be chromatograms that show unexpected peaks, unexpected
results for stability test point.
非期望结果（OOE）：检测结果符合标准，但是该结果是不符合预期、有疑问的、非常规
的、异常的；比如检测图谱出现未知峰或是稳定性考察点中的异常非预期检测结果。

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