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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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| Pubblicato in: | Eur J Clin Pharmacol |
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| Autori principali: | , , , , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Springer Berlin Heidelberg
2016
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| Soggetti: | |
| Accesso online: | 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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