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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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| Опубликовано в: : | Eur J Clin Pharmacol |
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| Главные авторы: | , , , , |
| Формат: | Artigo |
| Язык: | Inglês |
| Опубликовано: |
Springer Berlin Heidelberg
2016
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| Предметы: | |
| Online-ссылка: | 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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