Application of equivalence testing in similarity evaluation of biological activity assay methods for glucagon like peptide-1(GLP-1) receptor agonist drugs
10.13200/j.cnki.cjb.004506
- VernacularTitle:等效性检验法在胰高血糖素样肽-1受体激动剂药物生物学活性测定法相似性评价中的应用
- Author:
WANG Mingren
- Publication Type:Journal Article
- Keywords:
Equivalence testing;
Glucagon like peptide-1(GLP-1);
Receptor agonist;
Biological activity;
Potency;
Similarity
- From:
Chinese Journal of Biologicals
2025;38(06):719-724
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the feasibility of applying equivalence testing to evaluate the similarity between reference standards and test samples in the biological activity assessment of glucagon like peptide-1(GLP-1) receptor agonist drugs,so as to improve the determination standard of biological activity of various products.Methods Historical release biological activity data from 25 batches of products were collected,and the parameter estimates and standard errors of a four-parameter logistic model were obtained.The slope ratio of test samples to reference standards and dynamic range ratio(ratio of the difference between upper and lower asymptotes of test samples to that of reference standards) were selected as similarity evaluation metrics,and tolerance interval method was used to set equivalence margins for these metrics.Subsequently,biological activity data from 86 additional batches of GLP-1 receptor agonist drugs(57 reference standards with similar biological behaviors to those of test samples and 29 reference standards with non-similar biological behaviors) were analyzed using equivalence testing to determine similarity.For comparison,an F-test was also performed to assess parallelism.The agreement between the two methods was evaluated using Kappa test.Results The equivalence intervals for the slope ratio and dynamic range ratio were 0.64-1.56 and 0.87-1.15,respectively.For the 86 batches,equivalence testing correctly identified 95%(54/57) of truly similar samples as similar and 86%(25/29) of non-similar samples as non-similar.In contrast,the F-test correctly identified 88%(50/57) of parallel samples as parallel and 72%(21/29) of non-parallel samples as non-parallel.Kappa test indicated moderate agreement between the two methods(Kappa=0.417).Conclusion Equivalence testing is suitable for evaluating similarity in the biological activity of GLP-1 receptor agonist drugs and outperforms the F-test in similarity assessment.
