Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

This paper represents the consensus views of a cross-section of companies and organizations from the USA and Canada regarding the validation and application of liquid chromatography tandem mass spectrometry (LC-MS/MS) methods for bioanalysis of protein biotherapeutics in regulated studies. It was pr...

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Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Jenkins, Rand, Duggan, Jeffrey X., Aubry, Anne-Françoise, Zeng, Jianing, Lee, Jean W., Cojocaru, Laura, Dufield, Dawn, Garofolo, Fabio, Kaur, Surinder, Schultz, Gary A., Xu, Keyang, Yang, Ziping, Yu, John, Zhang, Yan J., Vazvaei, Faye
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2014
Assuntos:
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Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4287296/
https://ncbi.nlm.nih.gov/pubmed/25392238
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-014-9685-5
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