Joint analysis of PK and immunogenicity outcomes using factorization model - a powerful approach for PK similarity study.

ABSTRACT: Biological products, whether they are innovator products or biosimilars, can incite an immunogenic response ensuing in the development of anti-drug antibodies (ADA). The presence of ADA's often affects the drug clearance, resulting in an increase in the variability of pharmacokinetic (PK) analysis and challenges in the design and analysis of PK similarity studies. Immunogenic response is a complex process which may be manifested by product and non-product-related factors. Potential imbalances in non-product-related factors between treatment groups may lead to differences in antibodies formation and thus in PK outcome. The current standard statistical approaches dismiss any associations between immunogenicity and PK outcomes. However, we consider PK and immunogenicity as the two correlated

SUBMITTER: Haliduola HN 

PROVIDER: S-EPMC9547438 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature