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A mechanistic pharmacokinetic model with drug and antidrug antibody interplay, and its application for assessing the impact of immunogenicity response on bioequivalence testing

AIMS: Single‐dose pharmacokinetic (PK) studies in healthy subjects have been the design of choice for bioequivalence determination for decades. This preference has been recently extended to PK similarity studies of proposed biosimilars. However, PK similarity studies can be complicated by the effect...

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Detalles Bibliográficos
Autores principales:	Liao, Kai H., Udata, Chandrasekhar, Yin, Donghua, Sewell, K. Lea, Kantaridis, Constantino, Alvarez, Daniel F., Meng, Xu
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2020
Materias:	Original Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7576624/ https://www.ncbi.nlm.nih.gov/pubmed/32285955 http://dx.doi.org/10.1111/bcp.14312

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