Objective: To explore the criteria for successful method verification and transfer. Methods: Combining with advancements in methodological research in recent years,especially the advancements in the application of statistics in this field,the unclear issues were analyzed in the current guidelines or literature about methods verification/transfer,and the criteria were discussed for successful method verification and transfer by introducing predictive interval,tolerance interval and method capability index. Results: Analysis method verification/transfer protocol followed the protocol of method validation,and the experimental design only required the experimenter to repeat the operation independently according to the requirements of method validation. If the reported value obtained was within the prediction interval of the method validation results,the method verification/transfer could be judged successful. If the report value exceeded the tolerance interval of method validation results,the method verification/transfer could be judged unsuccessful. If the report value was between the tolerance interval and the prediction interval,attention should be paid to the experimental process and further improvement should be attempted. In addition,the method capability index could also be used for determination of verification/transfer. Conclusion: When using the new experiment design mentioned here for method verification/transfer,there are obvious advantages to use the following approaches as criteria to judge whether the method verification/transfer are successful. One is comparing the reported value obtained from method verification/transfer with the prediction interval and tolerance interval from method validation and the other is assessing by calculating the method capability index. At the same time,it can effectively reduce the risk of misjudgment caused by the method verification/transfer process.
LI Na, GENG Ying, TAN De-jiang, YANG Hua-xin, ZHU Rong-die, MA Li, XU Hui, ZHANG Qing-sheng
. Discussion on the criteria for successful method verification and transfer*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(4)
: 675
-680
.
DOI: 10.16155/j.0254-1793.2021.04.14
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