For the evaluation indicators with statistical differences in the subchronic toxicity test, the test report should clarify whether the relevant differences impact on biological evaluation results and explain the reasons, analyze and determine the relationship between the relevant differences and the tested product, instead of simply listing items with statistical differences. The administrative counterpart should analyze and evaluate the abnormalities or risks indicated in the test report. In addition, it is necessary to provide the basis for the determination of the test dose and consider the safety factor for extrapolation of the dose to human beings.
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