Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

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Cutting-edge mass spectrometry methods for the multi-level structural characterization of antibody-drug conjugates.

P2860

Q38665164-49293157-376C-4941-9E28-28B6CBECFA84

P2860

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

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2015 nî lūn-bûn

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2015年の論文

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2015年論文

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2015年論文

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2015年論文

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2015年論文

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2015年論文

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2015年论文

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2015年论文

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Workshop Report: AAPS Workshop ...... s in the Regulated Environment

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Workshop Report: AAPS Workshop ...... s in the Regulated Environment

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Workshop Report: AAPS Workshop ...... s in the Regulated Environment

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P1476

Workshop Report: AAPS Workshop ...... s in the Regulated Environment

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P2093

Binodh DeSilva

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Brian Booth

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Eric Wakshull

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Joao Pedras-Vasconcelos

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Lauren Stevenson

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Marian Kelley

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Marie Rock

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Michaela Golob

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Rand Jenkins

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Roland F Staack

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P2860

Bioanalytical approaches to quantify "total" and "free" therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development.

Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidance.

Key elements of bioanalytical method validation for macromolecules.

Appropriate calibration curve fitting in ligand binding assays.

Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.

Free analyte QC concept: a novel approach to prove correct quantification of free therapeutic protein drug/biomarker concentrations.

Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification.

Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules.

P2888

s12248-015-9767-z

P304

1019-1024

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scholarly article

case report

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10.1208/S12248-015-9767-Z

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P407

English

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P478

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P577

2015-04-30T00:00:00Z

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275661803

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1026330973

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25921938

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P921

workshop

ligand binding

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4476978

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Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

about

P2860

P2860

Workshop Report: AAPS Workshop on Method Development, Validation, and Troubleshooting of Ligand-Binding Assays in the Regulated Environment

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type

label

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P1433

P1476

P2093

P2860

P2888

P304

P31

P356

P407

P433

P478

P577

P5875

P6179

P698

P921

P932

P356

P1433

P1476

P2093

P2860

P2888

P304

P31

P356

P407

P433

P478

P577

P5875

P6179

P698

P921

P932