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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Argitaratua izan da:Eur J Clin Pharmacol
Egile Nagusiak: Reijers, Joannes A. A., van Donge, T., Schepers, F. M. L., Burggraaf, J., Stevens, J.
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: Springer Berlin Heidelberg 2016
Gaiak:
Pharmacokinetics and Disposition
Sarrera elektronikoa:https://ncbi.nlm.nih.gov/pmc/articles/PMC5055907/
https://ncbi.nlm.nih.gov/pubmed/27515979
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s00228-016-2101-6
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