Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies

PURPOSE: Population pharmacokinetic analyses (PPK) have been used to establish bioequivalence for small molecules and some biologicals. We investigated whether PPK could also be useful in biosimilarity testing for monoclonal antibodies (MAbs). METHODS: Data from a biosimilarity trial with two trastu...

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Detalles Bibliográficos
Autores principales: Reijers, Joannes A. A., van Donge, T., Schepers, F. M. L., Burggraaf, J., Stevens, J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2016
Materias:
Pharmacokinetics and Disposition
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055907/
https://www.ncbi.nlm.nih.gov/pubmed/27515979
http://dx.doi.org/10.1007/s00228-016-2101-6

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055907/
https://www.ncbi.nlm.nih.gov/pubmed/27515979
http://dx.doi.org/10.1007/s00228-016-2101-6

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