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Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies

In this work, a previously developed pegfilgrastim (PG) population pharmacokinetic-pharmacodynamic (PKPD) model was used to evaluate potential factors of importance in the assessment of PG PK and PD similarity. Absolute neutrophil count (ANC) was the modelled PD variable. A two-way cross-over study...

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Detalles Bibliográficos
Autores principales: Brekkan, Ari, Lopez-Lazaro, Luis, Plan, Elodie L., Nyberg, Joakim, Kankanwadi, Suresh, Karlsson, Mats O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6614128/
https://www.ncbi.nlm.nih.gov/pubmed/31286293
http://dx.doi.org/10.1208/s12248-019-0349-3