Roles and Drawbacks of Abnormal Toxicity Test in Quality Control of Biological Products
The abnormal toxicity test,as one of the important safety test items for biological prod-ucts,is mostly used to find out whether a sample is contaminated with exogenous toxic substances and whether there is any unexpected risk to safety.The methods for conducting abnormal toxicity tests boast a long history,yet there have been no significant improvements to the testing method so far.Relevant research indicates that the abnormal toxicity test is facing such issues as the lack of specificity,inadequate standardization and noncompliance with animal welfare principles,thus resulting in insufficient rationale of the test.Besides,with the implementation of Good Manufacturing Practice and advancements in pharma-ceutical manufacturing technology,the abnormal toxicity test has not demonstrated its effectiveness in identifying quality issues in retrospective studies,indicating the limited applications of the test.In this paper,we review the evolution of the abnormal toxicity test,discuss its role and drawbacks,and offer suggestions for future development,namely,the need to differentiate between new drugs and marketed drugs in order to gradually phase out the abnormal toxicity test.
abnormal toxicity testbiological products safety test
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