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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...
Sparad:
| I publikationen: | AAPS J |
|---|---|
| Huvudupphovsmän: | , , , |
| Materialtyp: | Artigo |
| Språk: | Inglês |
| Publicerad: |
Springer US
2015
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| Ämnen: | |
| Länkar: | 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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