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

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) a...

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Bibliographic Details
Main Authors: Halimu N. Haliduola, Fausto Berti, Heimo Stroissnig, Eric Guenzi, Hendrik Otto, Abid Sattar, Ulrich Mansmann
Format: Article
Language:English
Published: BMC 2022-10-01
Series:BMC Medical Research Methodology
Subjects:
Biosimilars
PK similarity
Immunogenicity
Factorization model
Bioequivalence
Online Access:https://doi.org/10.1186/s12874-022-01742-2

Internet

https://doi.org/10.1186/s12874-022-01742-2

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