Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.
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Measuring Oxytocin and Vasopressin: Bioassays, Immunoassays and Random NumbersImpact of Sample Matrix on Accuracy of Peptide Quantification: Assessment of Calibrator and Internal Standard Selection and Method Validation.Performance metrics for evaluating system suitability in liquid chromatography--Mass spectrometry peptide mass mapping of protein therapeutics and monoclonal antibodies.Strategies for improving sensitivity and selectivity for the quantitation of biotherapeutics in biological matrix using LC-MS/MS.Generic method approaches for monoclonal antibody therapeutics analysis using both ligand binding and LC-MS/MS techniques.Qualitative and quantitative characterization of protein biotherapeutics with liquid chromatography mass spectrometry.LC-MS/MS Validation Analysis of Trastuzumab Using dSIL Approach for Evaluating Pharmacokinetics.A workflow for absolute quantitation of large therapeutic proteins in biological samples at intact level using LC-HRMS.Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated EnvironmentValidation of a biotherapeutic immunoaffinity-LC-MS/MS assay in monkey serum: 'plug-and-play' across seven molecules.Do we have a mature LC-MS/MS methodology for therapeutic monoclonal antibody bioanalysis?Quality control in mass spectrometry-based proteomics.The Validation of Quantitative Mass Spectrometry Assays for Clinical Chemistry Assessments in Animal Models.Antibody-drug conjugate bioanalysis using LB-LC-MS/MS hybrid assays: strategies, methodology and correlation to ligand-binding assays.2D-LC-MS/MS to measure cleaved high-molecular-weight kininogen in human plasma as a biomarker for C1-INH-HAE.Toward best practices in data processing and analysis for intact biotherapeutics by MS in quantitative bioanalysis.Practical considerations in enhancing LC-MS sensitivity for therapeutic protein bioanalysis.Novel strategy using tryptic peptide immunoaffinity-based LC-MS/MS to quantify denosumab in monkey serum.Measurement of lipid transfer proteins in genetically engineered maize using liquid chromatography with tandem mass spectrometry (LC-MS/MS).LC-MS/MS strategies for therapeutic antibodies and investigation into the quantitative impact of antidrug-antibodies.Evaluation of the potential use of hybrid LC-MS/MS for active drug quantification applying the 'free analyte QC concept'.Reagent-free LC-MS/MS-based pharmacokinetic quantification of polyhistidine-tagged therapeutic proteins.Quantitative bottom up analysis of infliximab in serum using protein A purification and integrated μLC-electrospray chip IonKey MS/MS technology.Immunoaffinity MS: adding increased value through hybrid methods.A whole-molecule immunocapture LC-MS approach for the in vivo quantitation of biotherapeutics.LC-MS quantification of protein drugs: validating protein LC-MS methods with predigestion immunocapture.Immunoaffinity-coupled MS: best of both technologies.Bioanalytical method validation considerations for LC-MS/MS assays of therapeutic proteins.
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P2860
Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.
description
2014 nî lūn-bûn
@nan
2014年の論文
@ja
2014年学术文章
@wuu
2014年学术文章
@zh
2014年学术文章
@zh-cn
2014年学术文章
@zh-hans
2014年学术文章
@zh-my
2014年学术文章
@zh-sg
2014年學術文章
@yue
2014年學術文章
@zh-hant
name
Recommendations for validation ...... s for protein biotherapeutics.
@en
Recommendations for validation ...... s for protein biotherapeutics.
@nl
type
label
Recommendations for validation ...... s for protein biotherapeutics.
@en
Recommendations for validation ...... s for protein biotherapeutics.
@nl
prefLabel
Recommendations for validation ...... s for protein biotherapeutics.
@en
Recommendations for validation ...... s for protein biotherapeutics.
@nl
P2093
P2860
P1433
P1476
Recommendations for validation ...... s for protein biotherapeutics.
@en
P2093
Anne-Françoise Aubry
Dawn Dufield
Fabio Garofolo
Faye Vazvaei
Gary A Schultz
Jean W Lee
Jeffrey X Duggan
Jianing Zeng
P2860
P2888
P356
10.1208/S12248-014-9685-5
P407
P577
2014-11-13T00:00:00Z
P5875
P6179
1010000105