Scientific design of experiment (DOE) is the main tool to ensure the accuracy of test results and the reliability of conclusions. It is discussed the validation design for bioassay with many influencing factors and great variation, and the calculation method of sample size in method validation design is elaborated in detail here. It is hoped that it could provide theoretical reference for bioassay valiadation to accurately understand the experimental design of method validation.
TAN De-jiang, DUAN Li, GENG Ying, HAN Lu, LI Na, DU Ying
. Discussion on the experiment design of bioassay validation*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(6)
: 962
-965
.
DOI: 10.16155/j.0254-1793.2022.06.07
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