In Silico Evaluation of the Potential Impact of Bioanalytical Bias Difference between Two Therapeutic Protein Formulations for Pharmacokinetic Assessment in a Biocomparability Study

Formulation changes at later stages of biotherapeutics development require biocomparability (BC) assessment. Using simulation, this study aims to determine the potential effect of bias difference observed between the two formulations after spiking into serum in passing or failing of a critical BC st...

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Bibliografiske detaljer
Udgivet i:AAPS J
Main Authors: Thway, Theingi M., Macaraeg, Chris, Eschenberg, Michael, Ma, Mark
Format: Artigo
Sprog:Inglês
Udgivet: Springer US 2015
Fag:
Research Article
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC4406967/
https://ncbi.nlm.nih.gov/pubmed/25739817
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9741-9
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