Objective: To explore the establishment method and evaluation criteria of dose-effect model of bioassay. Methods: Combined with the latest research progress in dose-effect model, the dose-effect model in bioassay was reviewed and analyzed from its importance, the common dose-effect models, the problems to be solved before model establishment, and the basic steps needed for model establishment. Results and conclusions: (1) The modeling of dose-effect relationship is an important evaluation content before bioassay validation at present, and it is the starting point of method risk assessment. (2) There are many model types in bioassay, including not only linear model, but also polynomial model, logistic model, brain cousins model, specificity and non-specificity model for single-site and double-site specific combination for quantitative data, and probit model for qualitative data, etc. (3) Before the establishment of the model, it is necessary to combine professional and statistical knowledge for interdisciplinary communication, find out the bio-response window, determine the number of dose and the number of repetitions at each dose through pre-experiments, conduct reasonable experimental design, and predetermine the evaluation approach and acceptance criteria of the model. (4) The basic steps for model establishment include evaluating whether each response value is independent, whether the residual value is in normal distribution and homogeneity, and finally, the selection of optimal model from similar models, etc.
TAN De-jiang, HAN Lu, DUAN Li, LI Na, DU Ying
. Discussion on how to set up the dose-response model of bioassay*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(6)
: 942
-950
.
DOI: 10.16155/j.0254-1793.2022.06.04
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